Validity of patents
ROHIT KUMAR SHUKLA, LL.M.
(Querist) 13 October 2011
This query is : Resolved
what is the validity of patent?
Any recent judgement on the validity of patents under the patent act, 1970
R.Ramachandran
(Expert) 13 October 2011
Dear Mr. Rohit,
Your query is not understandable. You have to be little more clear in your query?
prabhakar singh
(Expert) 13 October 2011
A patent is the right to exclude others from making, using, or selling the claimed invention for a limited time.
The invention must meet the following requirements in order to be patentable:
1. Novelty: It must be different from the prior art and have no prior publication, use or sale more than one year prior to its application.
2. Usefulness: It must function to carry out the object of the invention, be practical and be makeable or usable by one of ordinary skill in the art.
3. Non-obviousness: It must not have been obvious to one of ordinary skill in the art at the time of the application.
prabhakar singh
(Expert) 13 October 2011
Intas Laboratories Pvt. Ltd. And ... vs Novaritis A.G., ... on 20 December, 2004
Equivalent citations: 2005 (1) CTC 27
Author: P Dinakaran
Bench: P Dinakaran, S Singharavelu
ORDER
P.D. Dinakaran, J.
1. These appeals are directed against the common order dated 28.4.2004 made in O.A.No. 13/2004 and A.No. 1218 of 2004 in C.S.No. 5 of 2004; O.A.No. 14 of 2004 & A.No. 1076 of 2004 in C.S.No. 6 of 2004; O.A.No. 15 of 2004 and A.Nos. 841, 842 and 843 of 2004 in C.S.No. 7 of 2004; O.A.No. 16 of 2004 and A.Nos. 844, 845 and 846 of 2004 in C.S.No. 8 of 2004; and O.A. No. 17 of 2004 and A.Nos. 847, 848 & 849 of 2004 in C.S.No. 9 of 2004 filed by the respondents herein/plaintiffs in the respective suits, wherein the learned single Judge made absolute the order of ex parte injunction dated 20.01.2004 made in O.A.Nos. 13 to 17 of 2004 in C.S.No. 5 to 9 of 2004 in favour of the respondents/plaintiffs in each of the suits and dismissed the applications filed by the appellants/defendants to vacate the ex parte order of injunction dated 20.1.2004 in each of the suits.
2. The respondents/plaintiffs filed the above suits, viz., C.S.Nos. 5 to 9 of 2004 against the appellants herein/defendants in the suit for a common relief, namely:
(a) for a decree of permanent injunction restraining the respective defendants, their directors, their partners, servants, agents, licensees, and distributors and anyone claiming through them from manufacturing, for sale, distributing, selling, marketing and/or exporting their and cancer drug composed of "Beta-Crystalline form of Imatinib Mesylate" under the mark/name
"IMATIB","IMALEK","IMANIB","ZOLETA" and "TEMSAN" respectively or any other brandname/mark or otherwise; so long as the Exclusive Marketing Right granted by the Controller of Patents on 10.11.2003 under EMR No. 002 and notified in the Official Gazette on 13.12.2003 is subsisting;
(b) for a direction to the respective defendants to render a true and faithful account of the profits made by the defendants by selling the anti cancer drug being the "Beta-Crystalline form of Imatinib Mesylate" under any mark or otherwise by a preliminary decree;
(c) for a decree that the entire stock of the impugned drug in the custody or possession of each defendant be forthwith seized and kept in the custody of the Hon'ble Court or the custody thereof be handed over to the plaintiffs' and/or their representatives/ agents.
3.1. The common case of the respondents/plaintiffs in all the suits is that:
(i) India, as a member of World Trade Organisation and by virtue of it's agreement on trade related aspects of intellectual property rights (TRIPS AGREEMENT), is under an obligation to consider granting product patent in all fields, including medicines and drugs with effect from 1.1.2005;
(ii) by way of an interim measure, till the product patent application is taken up for consideration, provision is made in the Patents Act for granting Exclusive Marketing Rights (hereinafter referred to as 'EMR');
(iii) the first plaintiff filed a patent application in India on 17.7.1998 for the product patent referred to above;
(iv) the first plaintiff filed an application in a convention country, i.e., Australia on 16.7.1998 claiming patent for the identical product;
(v) marketing approval to sell the identical product was granted in Australia on 13.8.2001 followed by the proceedings dated 28.2.2002, by which, the patent product was granted in Australia;
(vi) on 4.12.2001, marketing approval for an identical product was granted in India in favour of the second plaintiff by the Drug Controller General;
(vii) on 27.3.2002, the plaintiff filed an application with the patent office Kolkata for an "EMR" for the patent product and "EMR" was granted on 10.11.2003;
(viii) "EMR" confers an exclusive right to sell or distribute the drug referred to earlier for a period of five years or till an order is passed in the patent claim in India either way, whichever is earlier; and
(ix) the Drug Controller of India had given marketing approval to the second plaintiff for the drug in question by order dated 5.12.2002 valid for the period from 1.1.2003 to 31.12.2005 and the defendants, either in their capacity as the manufacturer or distributor, are infringing the rights of the plaintiffs, given under the "EMR", by dealing with the same drug.
3.2. It was thus contended by the respondents/plaintiffs that they have obtained a valid EMR from the authorities concerned; the balance of convenience lies in their favour; the element of public interest has also been taken care of for supply of free GLIVEC medicine by the programme called as GIPAP programme and therefore, if injunction is not granted, the respondents/plaintiffs would suffer irreparable loss.
3.3. Incidentally, it was also contended by the respondents/plaintiffs that, assuming if any public interest suffers on account of the price determined by the authority, the Central Government alone can, by notification, pass appropriate directions exercising the power conferred under Section 24-D(2) of the Patents Act.
4. Pending the above suits, the respondents/plaintiffs sought for an order of interim injunction, which is identical in all the Original Applications and based on the above pleadings, the learned Single Judge, granted ex parte injunction on 20.1.2004, as modified by an order dated 26.2.2004.
5. Aggrieved by the grant of ex parte interim injunction by order dated 20.1.2004, as modified by the order dated 26.2.2004, the appellants/ defendants filed applications to vacate the order of ex parte injunction dated 20.1.2004.
6.1. The suits were resisted by the appellants/defendants as follows:
(i) The first plaintiff filed a patent claim in "US" on 28.4.1994 titled "Pyrmidine derivatives and processes for the preparation thereof, priority for this application was claimed from "Swiss" patent application filed on 1.4.1992;
(ii) this patent was granted by "US" on 28.5.1996 disclosing "Mesylate Salt of Imatinib";
(iii) for the same invention, the plaintiff filed a patent claim in "Canada" on 1.4.1993 basing again the priority on the "Swiss" patent application referred to earlier;
(iv) "Canada" granted patent on 26.11.2002;
(v) no patent for "Imatinib Mesylate" was ever filed in India and therefore, there is no question of the plaintiffs entitled to any protection on the basis of any patent that may still subsist abroad for "Imatinib" per se or for the "Mesylate Salt of Imatinib";
(vi) no patent can be granted, if the said subject matter was claimed elsewhere, before the priority date claimed in India;
(vii) the first plaintiff filed a patent application in India on 17.7.1998 titled "Crystal modification of a N-Pheny - 2 - Pyrimidineamine derivative process for it's manufacture and it's use;
(viii) for this application, the priority date is 18.7.1997 Switzerland;
(ix) on the date of filing the patent application in India, Switzerland was not a convention country and it was notified as a convention country only on 28.9.1998 and therefore, no patent can even be granted in India to the invention referred to above;
(x) the first plaintiff obtained a patent in Australia based on the priority on the "Swiss" patent application of July 18, 1997;
(xi) the "EMR" issued in this case does not disclose the specific substance claimed in the Australian patent, on which it is based;
(xii) the "EMR" granted is vague and indefinite;
(xiii) the first plaintiff is trying to create a monopoly and to take the entire profits out of the sale of drugs covered under the "EMR", adversely affecting the interest of the patients in India;
(xiv) the cost of one capsule marketed by the plaintiffs is Rs. 1,700 whereas the cost of the drug in question sold by the Indian manufacturer averages less than Rs. 100 per capsule;
(xv) taking the price tag, the cost of the plaintiffs' product per year would be approximately Rs. 25 Lakhs while the same would be Rs. 1-1/2 lakhs for an Indian drug;
(xvi) India being a poor country, many cannot afford to buy the plaintiffs' product and ultimately, they would die untreated;
(xvii) the plaintiffs have to establish that the "EMR" was validly granted and it is being infringed;
(xviii)appropriate tests have never been carried out in Australia in relation to "Beta-Crystalline form of Imatinib Mesylate" and therefore, granting marketing approval without conducting tests in Australia is not valid;
(xix) here also, the permission to import "Imatinib Mesylate" to India was not granted to the first plaintiff but only to the second plaintiff; and
(xx) the "EMR" holder and the import licence holder must be the same and that not being the case here, the injunction must be vacated.
6.2. The appellants/defendants thus contended that in a suit complaining infringement of a patent, in the instant case the EMR, the plaintiffs must make out a strong and prima facie case for the issue of a temporary injunction. Since a serious controversy exists as to whether or not the invention claimed by the respondents/plaintiffs is a new one or a new manufacture or whether or not the invention involves any new inventive skill having regard to what was known or used prior to the date of the patent, it may not be just and proper to pass an order of interim injunction restraining the appellants/defendants from pursuing their normal business activities.
7. After hearing both sides, the learned Single Judge, by order dated 28.4.2004 finding that the balance of convenience lies in favour of the respondents/plaintiffs in each of the suits and that the public interest had also be taken care of by the GIPAP programme, made absolute, the order of ex parte injunction granted on 20.01.2004 and dismissed the applications filed to vacate the ex parte injunction. Hence, the above appeals.
8. We heard the elaborate arguments made on both sides, reiterating the contentions that were made before the learned Single Judge and we have given careful consideration to the same.
9. The main contention of the appellants/defendants is that the EMR obtained by the respondents/plaintiffs in each of the suits is not in accordance with the provisions of the Patents Act, 1970, as the conditions imposed under Section 24-B of the Patents Act, 1970 have not been satisfied by the respondents/plaintiffs and therefore, they are not entitled for an order of interim injunction with respect to the patent till it is five years old. In this regard reliance was placed on the decision in V. Manicka Thevar v. M/s. Star Plough Works, and Niky Tasha India Pvt. Ltd. v. M/s. Faridabad Gas Gadgets Pvt. Ltd., 1984 PTC 87. It is also contended that the GIPAP programme is not sufficient to protect the public interest and the same is nothing but self-serving.
10. On behalf of the respondents/plaintiffs, it was contended that as long as the EMR obtained by the respondents/plaintiffs from the authorities concerned under the provisions of the Patent Act, 1970, which is valid for five years or till the disposal of the patent application one way or other/ whichever is earlier, and until the same is revoked under due process of law, the right conferred under EMR in favour of the respondents/plaintiffs shall not be interfered with or infringed by the appellants/defendants in any manner; and in any event, since the GIPAP Programme takes care of the public interest, the appellants/defendants cannot have any grievance in that regard, and even if any public interest is involved with reference to the determination of the price of the suit product, they are at liberty to move the Central Government for necessary directions invoking the power of the Central Government conferred under Section 24-D(2) of the Patents Act, 1970.
11. From the above rival contentions made by either side on the validity of the EMR granted in favour of the respondents/plaintiffs in each of the suits, we are of the considered opinion that it would not be proper for us to decide the said issue in appeals arising out of interim orders as the same would render the suit itself infructuous leaving nothing for the trial, as any view, opinion or finding expressed in that regard would automatically be binding on the learned Single Judge in the trial. We are, therefore, inclined to eschew any of the findings of the learned Single Judge with reference to the validity of the EMR granted in favour of the respondents/plaintiffs in each of the suit and to test the order under appeal dated 28.4.2004 only within the parameters of the balance of convenience and public interest in question.
12.1. Since the learned Single Judge, based on the materials placed before him and exercising his discretion, arrived at the finding that the balance of convenience lies in favour of the respondents/plaintiffs, stressing more on the EMR granted in favour of the respondents/plaintiffs under Section 24-B of the Patents Act, 1970, the validity of which has to be tested only in the trial in the suits, we find it difficult to interfere with the same.
12.2. However, the contentions advanced on behalf of the appellants/defendants with respect to the public interest deserves serious concern as the public interest should not be made to suffer on account of legal battle between the trading parties, particularly in the case of supply of medicines for Chronic Myeloid Leukaemia.
13.1. In response to the concern expressed by this Court in the public interest, Mr. Habibulla Basha, learned Senior Counsel, of course based on the telephonic instructions from the respondents/plaintiffs, fairly came forward to relax the conditions imposed in the GIPAP programme in the public interest. Accordingly, the learned Senior Counsel for the respondents/ plaintiffs gave an undertaking to the following effect, pending disposal of the suit:
(a) the respondents/plaintiffs would supply Beta-Crystalline form of Imatinib Mesylate freely to all the patients, who are suffering from Chronic Myeloid Leukaemia and are earning less than Rs. 3,36,000 per month;
(b) in the case of patients suffering from Chronic Myeloid Leukaemia, who are entitled for insurance for Chronic Myeloid Leukaemia, any amount which falls short of insurance policy shall be met by the respondents/plaintiffs;
(c) similarly, in the case of patients suffering from Chronic Myeloid Leukaemia, who are covered under reimbursement scheme, any amount falling short of reimbursement shall be met by the respondents/plaintiffs; and
(d) "Beta-Crystalline form of Imatinib Mesylate" medicine required for the patients, who are diagnosed as suffering from Chronic Myeloid Leukaemia by whichever hospital, shall be supplied by the respondents/plaintiffs to the hospitals as per their requirement; and the hospitals while placing such orders shall also inform the respondents/plaintiffs, the amount that would be met by the insurance company (reimbursing authority) and the amount to be met by the respondents/plaintiffs.
13.2. However, Mr. Habibulla Basha, learned Senior Counsel appearing for the respondents/plaintiffs sought time till 22.12.2004 to enable the respondents/plaintiffs to file an affidavit of undertaking to the above effect.
14. Recording the undertaking of the learned Senior Counsel made on behalf of the respondents/plaintiffs, we confirm the order of interim injunction dated 28.4.2004 of the learned Single Judge granting time to the respondents/ plaintiffs till 22.12.2004 to file an affidavit to the above effect before the Registry, and pending disposal of the suits,
(i) the respondents/plaintiffs would supply Beta-Crystalline form of Imatinib Mesylate freely to all the patients, who are suffering from Chronic Myeloid Leukaemia and are earning less than Rs. 3,36,000 per month;
(ii) in the case of patients suffering from Chronic Myeloid Leukaemia, who are entitled for insurance for Chronic Myeloid Leukaemia, any amount which falls short of insurance policy shall be met by the respondents/ plaintiffs;
(iii) similarly, in the case of patients suffering from Chronic Myeloid Leukaemia, who are covered under reimbursement scheme, any amount falling short of reimbursement shall be met by the respondents/plaintiffs;
(iv) "Beta-Crystalline form of Imatinib Mesylate" medicine required for the patients, who are diagnosed as suffering from Chronic Myeloid Leukaemia by whichever hospital, shall be supplied by the respondents/plaintiffs to the hospitals as per their requirement; and the hospitals while placing such orders shall also inform the respondents/plaintiffs, the amount that would be met by the insurance company reimbursing authority) and the amount to be met by the respondents/plaintiffs;
(v) the parties are at liberty to agitate their respective contentions before the learned single Judge and the same shall be considered on merits, independently, without any reference to any of the views expressed by the learned single Judge in the order dated 28.4.2004 or being infringed by any of the observations made hereunder;
(vi) the respondents/plaintiffs shall also file a report in compliance of the above arrangement every month before this Court in the suit as to the supply of medicines;
(vii) the parties are at liberty to move the learned single Judge or My Lord, the Honourable Chief Justice for expeditious disposal of the suits;
(viii) if any difficultly arises in implementing the above arrangement, either of the parties are at liberty to move this Court by appropriate applications, if they are so advised; and
(ix) all the original side appeals are disposed of accordingly. No costs. Consequently, the connected C.M. Ps are closed.
prabhakar singh
(Expert) 13 October 2011
Bajaj Auto Ltd., State Of ... vs Tvs Motor Company Ltd. on 16 February, 2008
Equivalent citations: (2008) ILLJ 726 Mad, MIPR 2008 (1) 217
Author: P Jyothimani
Bench: P Jyothimani
JUDGMENT
P. Jyothimani, J.
1. The plaintiff in C.S. No. 979 of 2007 is the defendant in C.S. No. 1111 of 2007.
2. C.S. No. 1111 of 2007 is a suit filed under Section 108 of the Patents Act, 1970 for the relief of permanent injunction in respect of the plaintiff's patent No. 195904 and/or from using the technology/invention described in the said patent and/or manufacturing, marketing, selling, offering for sale or exporting 2/3 wheelers, including the proposed 125-CC FLAME motorcycle containing an internal combustion engine or any internal combustion engine or product which infringes the plaintiff's patent No. 195904, claiming of damages for infringement of patent to the extent of Rs. 10,50,000/- etc.
Pending the said suit, the plaintiff therein, namely Bajaj Auto Limited has filed O.A. 1357 of 2007 praying for an order of temporary injunction restraining the respondent from in any manner infringing the applicant's patent No. 195904 and/or from using the technology/ invention described in the said patent and / or manufacturing, marketing, selling, offering for sale or exporting 2/3 wheelers, including the proposed 125 cc FLAME motorcycle containing an internal combustion engine or any internal combustion engine or product which infringes the plaintiff's patent No. 195904.
3. Likewise, the plaintiff in C.S. No. 979 of 2907 M/s. TVS Motor Company Limited has filed the suit on the basis of groundless threat of infringement under Section 106 of the Patents Act, for declaring that the threats held out by the defendant on September 1 and 3, 2007 that the plaintiff is infringing the defendant's patent No. 195904 and that the defendant is proposing to take infringement action against the plaintiff are unjustified, for declaring that the plaintiff's product TVS Flame which uses 2 spark plugs with screw fitted sleeve and 3 valves does not infringe patent No. 195904 of the defendant, for permanent injunction restraining the defendant from continuing the issuance of threats that the plaintiff is infringing the defendant's patent No. 195904 directly or indirectly in any manner including by way of circulars, advertisements, communications orally or in writing to the plaintiff or any other person, and thereby interfering with the launch and sale of product TVS Flame apart from directing the defendant to compensate the plaintiff with a sum of Rs. 1 crore or as determined by this Court as damages sustained on account of the unjustified threats made by the plaintiff.
Pending the said suit, the plaintiff has filed O.A. 1272 of 2007 for an order of interim injunction restraining the respondent from interfering with the manufacture and marketing of applicant's products using IC engine with 3 valves and 2 spark plug.
4. This Court after hearing the respective counsel for the applicant and respondent, by an order dated 19.12.2007 has ordered in O.A. No. 1357 of 2007 in C.S. No. 1111 of 2007 as follows:
I have carefully gone through the records. It is stated that number of motorcycles have been booked as on date. The number of motorcycles booked is not ascertainable immediately. In such circumstances, it is ordered that the respondent shall not receive any further booking in respect of the motorcycles containing the disputed engine Technology patent. Insofar as the motorcycles already booked/ the respondent is at liberty to deliver them subject to the following direction: That is the respondent is directed to maintain accounts for the motorcycles so delivered. List the suit along with C.S. No. 979 of 2007, on 3.1.2008.
5. The respondent in the said 0. A. 1357 of 2007 in C.S. No. 1111 of 2007 has filed an appeal in O.S.A. No. 420 of 2007 against the above said order dated 19.12.2007. The Hon'ble First Bench of this Court by order dated 20.12.2007, has suspended the said order of the learned single Judge and on the basis of an agreement between the parties that applications for injunction in both the suits as well as the appeal were directed to be heard by the Bench on 04.01.2008, has issued direction making it clear that the appellant, M/s. TVS Motor Company Limited will not be entitled to claim any equity on account of sale of its motor bikes in the meantime.
6. As the matters were subsequently not posted, the applicant in O.A.No. 1357 of 2007 in C.S. No. 1111 of 2007, who is the plaintiff, namely, Bajaj Auto Limited, has filed Civil Appeal No. 523 of 2008 before the Hon'ble Supreme Court against the above said order of the Bench dated 20.12.2007. The Hon'ble Supreme Court, by order dated 18.01.2008, while setting aside the above said order of the Division Bench, has requested the single Judge to hear and dispose of the application as an interim application after parties have exchanged their respective affidavits, in the following words:
To put an end to the controversy, we set aside the impugned order passed by the Division Bench and we request the Single Judge to hear and dispose of the Application as an Interim Application after parties have exchanged their respective affidavits. They shall do so within one week from, today. We request the Single Judge to place the said Application for hearing on 29.01.2008.
We make it clear that from today till 29.01.2008 respondent will not book further orders. However, booking done before this day (i.e.18.01.2008) will not stand cancelled. This order will apply only till 28.01.2000. If for some reason, matter cannot be heard on 28.01.2000, Single Judge can be moved by party affected for appropriate interim orders.
7. It is by virtue of the above said directions, the above applications for injunction are posted before this Court.
8. When the applications were taken up for hearing on 29.01.2008, at the instance of the learned senior counsel appearing for the respondent in O.A.1357 of 2007 in C.S. No. 1111 of 2008, TVS Motor Company Limited, the following order was passed by consent and the applications in both the suits were heard in detail.
Heard the learned senior counsel Mr. C.A. Sundaram appearing for the applicant.
In view of the on going hearing, learned senior counsel appearing for the respondent in this application, viz., M/s. TVS Motor Company Limited on behalf of his clients submits and undertakes that the respondent shall not receive any further booking in respect of the motor cycle containing the disputed Engine Technology Patent. He also undertakes to maintain accounts for the motorcycles so delivered. The said undertaking is recorded.
Post the matter for further hearing on 30.01.2008.
9. In both the applications, the parties have exchanged their affidavit, counter affidavit, reply affidavit and rejoinder affidavit apart from filing the typed set of papers for the proper appreciation of the issue involved in these applications. I shall refer to the parties as arrayed in O.A.1357 of 2007 in C.S. No. 1111 of 2007, since that happens to be the suit filed for the relief against patent infringement.
10. According to the applicant Bajaj Auto Limited, it was granted Indian Patent No. 195904 in respect of a patent application titled "An Improved Internal combustion engine working on four stroke principle" with a priority date of 16th July 2002. The said invention relates to the use of twin spark plugs for efficient combustion of lean air fuel mixture in small bore ranging from 45 mm to 70 mm internal combustion engine working on 4 stroke principle. The respondent, M/s. TVS Motor Company Limited has launched motor bikes of 125-CC on 13/14.12.2007 under the trade mark 'FLAME' powered with a lean burn internal combustion engine of bore size 54.5 mm with a twin spark plug configuration, which according to the applicant, infringes its patent No. 195904.
10(a). According to the applicant, which is a Company of the Bajaj Group has invented a unique technology of using two spark plugs for efficient burning of lean air fuel mixture in a small bore engine in the size between 45 mm and 70 mm. The use of two spark plugs in large bore engines or in high performance/racing bikes was known in the Automobile industry. However, the above said invention of the applicant was not known. In the industry, in some of the cases of large bore engines, where more than one spark plug is employed, the addition of a second spark plug ensures acceptable probability of combustion initiation of at least one of the spark plugs. Therefore, in respect of large bore engines, the history of user of automotive engines proves that only a small portion of large bore engines have been deploying twin spark plugs. In cases of racing applications, twin plugs have been applied in small bore air cooled engines which are not lean burn. These engines were used twin plugs as a means of mitigating knock which also gave added reliability by preventing loss of ignition/misfire. The twin plugs were also known to be applied in stratified engines applies to homogeneous engines.
10(b). The small bore engines do not need the second plug as they inherently have short flame travel distances and good charge motion inside the cylinder. When the bore diameter goes up, the effect of flame propagation distance is not linear. Conversely, when the bore size comes down to a small bore, the effect on flame propagation distance collapses, therefore in small bore engines, single plugs were found to be quite adequate. However, majority of the large bore engines make do with a single plug, even today.
10(c). Therefore, in small bore non-racing engines, with the flame propagation requirements not being an issue with a single plug, the need to have more than one spark plug was never thought necessary which has also failed commercially unviable in the absence of the known advantages of a dual spark plug in a small bore lean burn engine, with the added cost of a second plug. Therefore, according to the applicant, its invention laid in teaching the potential of applying twin plugs in small bore engine in a specific engine running condition of lean burn, to derive positive merits of improved fuel efficiency and emission characteristics. The applicant's invention which is called "DTS-i Technology" is a step of providing a second spark plug in a small bore engine running lean, was never thought of or implemented in the automobile industry, which according to the applicant & results in better combustion in a comparatively shorter duration of time leading to reduction in emission and improved fuel consumption while maintaining the predetermined level of performance. It is also of great technical advancement resulting in fuel consumption.
10(d). A valid patent No. 195904 was granted to the invention of the applicant, titled as "An Improved Internal Combustion engine working on four stroke principle". The applicant has applied for the grant of the patent on 16.07.2002 and the patent was granted on 07.07.2005, which was published in Issue No. 28/2005 dated 29.07.2005. According to the applicant, there was no opposition filed by anyone including the respondent either before or after the grant of patent. According to the applicant, being the patentee, the essential features of its invention are:
(i) small displacement engine as reflected by a cylinder bore diameter between 45 mm and 70 mm.
(ii) combustion of lean air fuel mixtures;
(iii) using a pair of spark plugs to ignite the air fuel mixture at a predetermined instant. The invented product of the applicant is not known anywhere in the world and from 2003 till date the applicant has manufactured and sold more than 3.05 million vehicles with "DTS-i Technology". In the first eight months of the current financial year, the applicant has manufactured and marketed 814,393 two wheelers with "DTS-i Technology" out of a total of 1,501,241 two wheelers sold. Therefore, the said "DTS-i Technology" stated to have been invented by the applicant has accounted to 54.25% share of Bajaj two wheelers. They have spent considerable amount in marketing and advertising and received appreciation through out the world as recipients of various world awards and the product is of economic advantage of the country.
10(e). The applicant states that on 30.08.2007, the respondent (M/s. TVS Motor Company Limited) announced that it was planning to introduce seven new products which included a 125-CC motorcycle called FLAME. Since the website was not clear about the use of twin spark plugs, the applicant never thought that such technology of the respondent would infringe its right. When it was showcased by the respondent at Hosur to media persons, it was revealed that the respondent was intending to use twin spark plugs. It was on 30.08.2007, the applicant learnt that the proposed model of the respondent contained an engine infringing the applicant's patented technology and it was revealed that the essential features of the applicant's patent were adopted by the respondent's proposed model and therefore, the applicant has expressed its desire to protect its intellectual property right. The applicant has also learnt that only 7 days before the launch of the proposed 125-CC motorcycle, the respondent filed an application for revocation of applicant's patent No. 195904 before Indian Patents Appellate Board [in short, "IPAB"] under Section 64 of the Patents Act, 1970.
10(f). In October, 2007, the respondent filed the suit in C.S. No. 979 of 2007 before this Court under Sections 105 and 106 of the Patents Act, 1970 alleging that the statement made by the applicant on 01.09.2007 and 03.09.2007 constituted a groundless threat. They learnt that the respondent has also filed a suit for defamation against the applicant in the Bombay High Court. Contrary to the applicant's belief that the respondent would ensure sufficient changes made in the model before the same is introduced, the respondent on 13/14.12.2007 have launched 125-CC motorcycle 'FLAME', which infringed its patent and the respondent has also issued press notification expecting to sell 20,000 motorcycles a month priced at Rs. 45,000/- each. The patent granted to the applicant is valid and subsisting. Therefore, the release by the respondent of the above said motorcycle containing 4 stroke combustion engine in small bore lean burn engine of size 54.5mm x 53.5mm and combusting lean air fuel mixture infringes the applicant's patent. The applicant also states that the admitted case of the respondent that it is using 3 valves in the engine does not dilute the infringement committed by the respondent since the number of valves is not an essential feature of the applicant's invention.
10(g). The specifications of the respondent in respect of TVS Flame 125-CC launched by it clearly show the similarities between the patenting technology of the applicant and the specification launched by the respondent. It is the further case of the applicant that if an order of injunction is not granted against the respondent, the statutory right of monopoly conferred on the applicant by virtue of the patent will become illusory and the use by the respondent would severely prejudice the statutory right apart from damaging the reputation and goodwill, which cannot be compensated in pecuniary terms. . The damage, which may be caused by the infringing act will have telling effect on the market share loss, relative position in the industry, impact on competitiveness, impact on industry rankings etc. of the applicant, which cannot be measured in terms of money. The applicant also states that it has launched its motorbike with effect from the year 2003 and steadily increased the sale in these long four years, whereas the respondents have launched "FLAME" 125-CC motorbike only on 14.12.2007 and they have not sold the said motorbike on an extensive scale and therefore, the applicant is entitled for an order of injunction.
The above said averments are the applicant's counter in O.A. No. 1272 of 2007 in C.S. No. 979 of 2007 filed by the respondent herein.
11. The respondent in the counter would state that the applicant has unjustly threatened and defamed the respondent to secure illicit market advantage for its product over that of the respondent, instead of moving the Court to seek justice. According to the respondent, there are inherent and explicit contradictions in the stand of the applicant as it is seen in the various documents relied upon by the applicant for protection of its Patent No. 195904. According to the respondent, the use of two spark plugs in an IC engine with three valves was a prior art and therefore, the applicant cannot seek patent for the use of two spark plugs in an IC engine, and in order to avoid the said situation, the applicant has resorted to an art of deception by introducing a limitation of bore size to the US Honda patent with full knowledge that US Honda patent did not have any such limitation.
11(a). According to the respondent, by filing an application for revocation of patent given to the applicant, the respondent has questioned the very validity of Patent No. 195984 on several grounds. It is the case of the respondent that the content of the complete specification and amended complete specification and the claims made by the applicant would establish that the applicant is not entitled for the patent at all and the use of twin spark plugs in a small size bore engine cannot be said to be an inventive step. The alleged invention suffers from vice of obviousness. It is the further case of the respondent that the applicant is not entitled for an order of injunction due to delay and laches. The respondent has filed an application for revocation of the applicant's patent before the IPAB, Chennai even on 24.08.2007, the applicant has taken four months time to file reply, but has chosen to file the present suit. It is the case of the respondent that inasmuch as the very validity of the patent of the applicant is in question and the same is in challenge, the applicant is not entitled for any injunction. The applicant who does not know what is its invention cannot be said to have made a prima facie case for grant of an order of injunction.
11(b). According to the respondent it has not infringed the applicant's patent. Even in the event of applicant succeeding in the suit, it can be compensated in terms of money and therefore, no injunction can be granted against the respondent. The US Honda Patent No. 4534322 dated 13.08.1985 has been in the public knowledge for over 20 years and the construction of three valve configuration and their working, in the engine is protected by patent granted to AVL being US Patent No. 6250 146 and Patent No. 196636, on the basis of which the respondent has made claim and therefore, the patent granted to the applicant cannot be valid. According to the respondent, the claim of the applicant that it invented a spark plug centric engine comprising two spark plugs, which resulted in lean air fuel mixture is not an invention due to various reasons. While the applicant's claim is two spark plugs with two valves, the respondent's arrangement is two spark plugs with three valves. The applicant itself has conceded use of two spark plugs in small bore engine exists. The applicant has only attempted to confuse the functioning of IC engine and particularly that of the spark plugs and IC engine is common for automobiles, two wheelers, three wheelers and four wheelers and also for aeronautics. There are two kinds of IC engines, viz., 2 stroke and 4 stroke engines. While 2 stroke emission is otherwise amounting to pedalling, viz., up and down; the 4 stroke divides the 2 strokes into four functional strokes as what Americans called, "suck, squeeze, bang, blow" and the 4 stroke or four step is formalised by engineers as "intake stroke, compression stroke, power stroke and exhaust stroke".
11(c). The respondent has also explained the functioning of different components of the IC engine and transfer the power on to the wheels of the vehicle through the piston, which moves under above said four steps, viz., "intake stroke, compression stroke, power stroke and exhaust stroke". According to the respondent, out of the four steps, the spark plug comes in not to cause lean air fuel mixture, but to burn it. It is the further case of the respondent that the arrangement of installation of two spark plugs in the respondent's cylinder are exactly as per the arrangement in the expired Honda US Patent No. 4534322 dated 13.08.1985, which expired on 12.08.2005, which is the combination of two spark plugs with three valves and therefore, the respondent is entitled to use the same and the same is also based on AVL List GMBH Austria and licenced to the respondent. The licence given to the respondent is distinct and different from that of the applicant's patent No. 195984. It is also denied that the third valve in the three-valve arrangement of the respondent is ornamental. It is the further case of the respondent that the applicant has not chosen to challenge the licence granted in India in respect of the three valve arrangement of AVL despite the fact that even on 03.09.2007, the respondent has disclosed that its, three valve arrangement, founded on AVL patent. In the absence of challenge to AVL patent, it is open to the respondent to use the arrangement with the AVL patent.
11(d). The respondent further submits that the applicant has changed from plug centric description to valve centric description from the specification of the year 2003 and the amended specification of the year 2004 and according to the respondent the said change by the applicant was due to the existence of Honda US patent No. 4534322, wherein the Honda was using three valve system and the change was effected by the applicant only to distinguish from that of the Honda, which was in use from 1985 and is available for use by every one. The respondent also reiterate that,
(i) the concept of two spark plugs is known as prior art;
(ii) the claim of the applicant that use of two spark plugs in engines with narrow bore size of 45mm-70mm is known in prior arc and therefore the claim of the applicant is not correct; and
(iii) the third valve arrangement of the respondent is protected by patent licensed to it by AVL List GMBH.
The prior art is specified as single spark plug ignition and need of a richer or more mixture of fuel and air are erroneous and deliberate. The respondent also places reliance on various published papers like Indian Patent Number 678 dated 17.07.2001 titled "Spark Ignition Four-Cycle Engine", the use of twin spark plugs in lean burn engines is known as US Patent No. 5320075 dated 14.07.1994, titled "Internal Combustion Engine with Dual Ignition for a lean burn" apart from Harish Chandra, a critical study of the dual versus single plug system in S.I. Engines, SAE technical paper to substantiate its stand of prior publication. That apart, the respondent has also referred to Takegawa Cylinder heads and Honda Bros, NC 25E. Apart from Kawasaki KZ 1000 SI, Kawasaki KZ 1000 SI has the configuration of two valves per cylinder with twin plugs, cylinder bore size is 69.4mm. The respondent also refers to Honda NT 400, an advertisement by M/s. Worlds End Motorcycles Ltd., a spare parts seller in UK and the Honda NT 400 as per the specification stated above, contains 2 cylinders with each cylinder has a bore size of 64mm with 2 spark plugs per cylinder.
11(e). According to the respondent, the engine in its vehicle "FLAME" is based on twin spark ignition with one spark plug on the cam chain side fitted into the cylinder head using a sleeve, which is thread fitted as against push-fitting sleeve as claimed by the applicant's patent No. 195904. The respondent also refers to various provisions of Patent Act, 1970 to state that there is no infringement of a patent unless each and every one of the claimed elements was present in the article, which is alleged to infringe the patent and further, such element also act in relation to one another in the manner claimed, and according to the respondent, its product is different from that of the applicant and therefore its product does not infringe the patent of the applicant by explaining the technical reasons. Therefore, the balance of convenience is in favour of the respondent and the applicant has not made out a prima facie case.
The above said contentions in the counter affidavit of the respondent is the averment in the affidavit filed by it in support of the application in O.A. No. 1272 of 2007 in C.S. No. 979 of 2007.
12. The applicant has also filed reply affidavit stating that there is no deviation or difference between the final complete specification and the amended specification. According to the applicant even in the year of 2005 and till now the Honda has not launched motorbikes with small bore engines having twin spark plugs for combustion of lean burn air fuel mixtures and Honda Patent 322 is neither in respect of small bore engine nor it teaches twin plugs in efficient combustion of lean mixture and the applicant has not concealed the Honda Patent 4534522. It is the further case of the applicant that the respondent has admitted in the counter affidavit that there is no limitation of bore diameter in Honda 322 Patent. However the essential feature of the applicant's Patent No. 195904 is different. The reply affidavit also explains the characteristics -of TVS FLAME as to how the third valve has no role to play in driving cycle condition and it is only ornamental. The additional valve does not materially affect the working of the applicant's invention. The applicant's objection is only in respect of respondent using of small bore 4 stroke engines involving twin spark plugs for improved combustion of lean fuel air mixture. It is also reiterated that the respondent has failed to explain as to why no one has launched motorbikes with twin spark plug small bore engines operating with lean air fuel mixtures "DTS-i Technology" prior to that of the applicant's invention throughout the world. The technical papers relied on by the respondent are not relatable to the invention of the applicant. In respect of the Takegawa cylinder head kits, they are tuning kits, used for improving power and' torque and are not used for lean burn.. In respect of Honda Shadow range, it relates to large 1100-CC capacity as shown in the 'Wikipedia'. The NT 400 Bros is a powerful 400-CC bike producing 37 BHP which has the output of 800-CC Maruti 800 car indicating that NT 400 runs on rich mixtures which is completely different from small bore engines operating with lean air fuel mixture and teachings of applicant's patent No. 195904.
13. The respondent has also filed a rejoinder affidavit reiterating its stand in the counter affidavit originally filed, stating that the applicant's invention is a prior art. The respondent has also chosen to state about the various technical literatures long back from 1979 regarding the lean bore system, which has been working in 92 mm engine by M/s. Oblander as per the document of the ImechE conference of 1999. It is the further case of the respondent that there is nothing in the applicant's claim for patent to suggest, why the prior art would not work on bore size between 45 and 70 mm. It is further reiterated that all the 3 valves in the respondent engine are open and functioning at all times. It is also the further case of the respondent that the respondent has received from the collaborators viz., M/s. AVL List GMBH a technical paper that AVL presented at the Society of Automotive Engineers Conference as long back as on 29.10.2002.
14. Mr. C.A. Sundaram, learned Senior Counsel appearing for the applicant while narrating the historical events to show that the applicant has spent enormous amounts on research and development from the year 1992-93, has submitted that AVL List GmbH, Austria from whom the respondent claims the right as licensee, was granted patent for 3 valve system and was not in respect of twin spark plugs in small bore engine operating with lean burn air fuel mixtures. Therefore, any agreement which the respondent stated to have entered with AVL List GmbH on 13.11.2000 cannot be a ground to come to a conclusion that the respondent has not infringed the patent of the applicant.
14(a). He would submit that the characteristic features of the applicant's invention as it is seen in the provisional specification, complete specification and amended specification with twin spark plugs small bore engine for improved combustion with lean burn air fuel mixture and therefore, the triple characteristic of the invention of the applicant are as stated above. According to the learned senior counsel, the basis of the invention of the applicant is that it was designed based on chemical correct ratio of air fuel for complete reaction of oxygen and fuel with the aim of concentration on fuel economy and such invention has never been in use throughout the world before the invention of the applicant.
14(b). The learned senior counsel would also submit on facts that the applicant's application along with provisional specification was on 16.07.2002 and the patent was granted on 29.07.2805 with priority date of 16.07.2002 and in fact, the product has been launched by the applicant in the year 2003. By launch of its bikes Bajaj Pulsar using invented "DTS-i Technology" and as per the statistics which are filed, ever since 2003 till date nearly 3.05 million vehicles have been sold and the applicant's market share has also increased.
14(c). According to the learned senior counsel, the applicant has made an application in the form of provisional specification on 16.07.2002 and has spent huge expenditure not only for research and development but also incurred advertising expenditure in respect of "DTS-i Technology" and ultimately, the complete specification was submitted on 07.07.2003, within the time stipulated under the Patents Act and the invention of the applicant relates to the improved lean burn small bore engine. He. has also submitted that the applicant's product which was launched as stated above was welcomed world wide and many awards have been given and therefore, prima facie the applicant has established marketing of the new products based on invention which has been duly patented in accordance with law by an order dated 29.07.2005 with priority date from the date of application viz., 16.07.2002. The patent has been given with essential features of invention as small displacement lean burn engines.
14(d). According to the learned senior counsel, in all these periods, no one has raised any objection including the respondent either pre or post grant of the patent. According to the learned senior counsel, the respondent having waited without raising any objection, suddenly has filed a revocation petition on 24.08.2007 under Section 64 of the Patents Act, 1970 before IPAB seeking to revoke the applicant's patent and within six days thereafter, announced the introduction of various products including 125-CC motorcycle called 'FLAME', which according to the learned senior counsel, shows the ulterior motive of the respondent. It is the contention of the learned senior counsel that the respondent has launched the product in the name of 'FLAME' on 14.12.2007, which happens to be Friday and on 17.12.2007, the applicant has filed the present suit in C.S. No. 1111 of 2007 for infringement and the interim order was granted by this Court on 19.12.2007 stating that the respondent should not book any further orders. Therefore, the respondent has not marketed its product yet.
14(e). According to the learned senior counsel, the technical collaboration stated to have been entered by the respondent with AVL List GMBH is relating to 3 valve converted from the existing 125-CC two valve engine and by the time the collaboration stated to have been entered by the respondent with the said AVL List GMBH, the applicant's technology in "DTS-i" has been widely successful throughout the world. The Honda group which is the leader in the automotives themselves have made it clear on 20.07.2005 that twin spark plugs will be the success in future stating that the new innovation with the engine called 100-CC to 125-CC class charged low friction engine achieve improved combustion efficiency introducing 2 spark plugs and the innovative process will improve the fuel economy by 13% compared to the level on 2005, and therefore, the learned senior counsel submits that by declaration of the Honda itself it is admitted that its product relate to higher CC large bore engine and not similar to the product of applicant's. Therefore, according the learned senior counsel, the applicant has made a prima facie case of not only the invention of the applicant in the said "DTS-i Technology", but also proved the success of the said invention which has been widely used throughout the world and marked successfully and therefore the invention of the applicant is not merely theoretical or hypothetical in nature, but it has been put in action.
14(f). He further submits that at this stage of interim application, while considering the prima facie case and the balance of convenience, the Patents (Amendment) Act, 2002 (Act 38 of 2002), which has come into effect from 20.05.2003 and Amendment Act 2005, which came into effect from 01.01.2005 have to be taken into consideration, since there are remarkable changes in the right of Patentee. Before the Amendment, the patentee was having, an exclusive right to use the patented product, whereas, after the amendment, as per Section 48 of the Patents Act, 1970, it gives an exclusive right to the patentee to prevent the third parties from using the patent. Therefore, according to the learned senior counsel, there is ample change, in the rights of the patentee, and in the light of the amended provisions of Section 48 of the Patents Act, more weight must be given to the patent already granted unless and until it is revoked in the manner known to law. It is his contention that even in respect of the definition "inventive step" which was substituted by the Amendment Act, 2005 it is relevant in the light of the patent granted to the applicant. He also referred to the provisional, complete and amended specifications made by the applicant to contend that there are no deviation and they were only explanation.
14(g). The learned senior counsel would submit that the action of the respondent in filing application for revocation of applicant's patent itself cannot result in the presumption that the patent granted to the applicant is invalid especially at the interim application stage. He would rely upon the judgment of this Court in K. Ramu v. Adyar Ananda Bhavan Muthulakshmi Bhavan 2007 (34) PTC 689. He would also submit that on the factual position, when the applicant had marketed the patented product even in the year 2003 and in these long four years the sales have been effected throughout the world in large numbers, the invention has been proved to be world worthy and therefore at this stage, prima facie case has been made out by the applicant about the validity of the patent especially in the light of the amended Section 48 of the Patents Act, 1970 and the applicant cannot be made to suffer the complexity of the trial and wait for a long period. He would also rely upon the Division Bench judgment of, the Delhi High Court in Telemecanigue & Controls (I) Limited v. Scheneider Electric Industries SA 2002 (24) PTC 632 and the judgement in Monsanto Company v. Starlffer Chemical Company 1984 FSR 574 to support his contentions.
14(h). It is his submission that the balance of convenience in granting an order of injunction is in favour of the applicant because the patent itself is for a period of 20 years and after expiry of the said period, everybody has the right to use the same and therefore, the loss which would be caused to the applicant in the event of not granting injunction, if the plaintiff succeeds in the suit cannot be compensated in terms of money. He would submit that the balance of convenience should be considered in a different angle in respect of patent and not as per the normal rules. He rely upon the judgment of Lord Buckley in Corruplast Limited v. George Harrison (Agencies) Ltd. 1978 (25) RPC
761. He submits that the respondent' s case that such a technique is already in existence is not correct. In any event, when the respondent has not objected to the specification of the applicant for nearly five years and variant by the respondent is not relating to two spark plugs but relating to three valves and also when the specific case of the applicant is that the third valve is only ornamental in nature, the same has to be proved during trial. According to the learned senior counsel, at the interim application stage the question of deciding the triable issue against the patentee would not arise, especially under Indian Law. In respect of infringement of patent, he would also rely upon section 104A of the Patents Act which was inserted by Act 38 of 2002 and also the judgment in The General Tire & Rubber Company v. The Firestone Tyre and Rubber Company Ltd. and Ors. 1972 RPC 457. He would refer to a Full Bench judgment of the Delhi High Court in Metro Plastic Industries (Regd.) v. Galaxy Footwear, Delhi to
contend that the applicant uses its patent was for a long period.
14(i). The learned senior counsel would submit that the essential features of the invention are what patentee says in pith and marrow by relying upon the judgment in Catnic Component Ltd. and Anr. v. Hill & Smith Ltd. 1982 RPC 183. The interpretation of specifications must be based on the knowledge of the skilled persons in that field using the common general knowledge existing at the time of specifications which is the relevant time by placing reliance on the judgment in Lubrizol Corporation and Anr. v. Esso Petroleum Co. Ltd. and Ors. 1998 RPC 727. He submits that the interpretation must be purposive in nature as held in Catnic Component Ltd. and Anr. v. Hill & Smith Ltd. 1982 RPC 183 and Kastner v. Rizla Ltd. and Anr. 1985 RPC 585 and the judgment in Sandow Ld. v. Szalaly 1906 RPC 6, Patent Exploitation, Ld. v. Siemens Brothers & Co. Ltd. 1903 RPC 225 and Muto Industrial Company Limited's Application 1978 RPC 70. He would also submit that if two interpretations of specifications are possible, the interpretation which validates the patent has to be adopted, by placing reliance on the judgment in William Needham and James Kite v. Johnson and Co. 1884 RPC 49. He further relied upon the judgment in Consolidated Car Heating Company v. Came 1903 (20) RPC 745, Raj Prakash v. Mangat Ram Choudhary and Ors. , William Needham and James Kite v. Johnson and Co. 1884 RPC 49 and Improver Corporation and Ors. v. Remington Consumer Products Ltd. and Ors. 1990 FSR 181 regarding variation claimed by the respondent. Therefore, according to the learned senior counsel, the applicant has proved the prima facie case and the balance of convenience in granting injunction is in favour of the applicant and any amount of damages cannot compensate any loss which may be caused to the applicant and in view of the same, he submits that order of injunction must be granted on the factual situation.
15. Per contra, Mr. AL. Somayaji, learned senior counsel for the respondent would submit that as per Section 10 of the Patents Act which speaks about the specifications, complete specification must meet the original claim made by a patentee and that should be taken as the scope of intention. His submission is that while deciding about the infringement of patent, the patentee property should be construed and it must be compared with the defendant's product. He submits that there is remarkable variation between the provisional specification, complete specification and amended specification made by the applicant in respect of its alleged invention. He submits that a reference to the provisional specification of the applicant shows decreased emission, decreased fuel consumption and good drivability and the same can never be treated as invention. On the other hand, he would submit that the applicant who has given in the provisional specification as valve centric has switched over to plug centric in the complete specification and there is no mention about the lean burn air fuel mixture or two valves except mentioning about the twin spark plugs. His further submission is that in the amended specification of 2004, once again the applicant has gone back to valve centric instead of spark plug centric, however, in the affidavit filed in support of the application for injunction, the applicant has chosen to explain about the spark plug centric and therefore, different stands have been taken by the applicant at different points of time and it is not known as to what is the patent of the applicant. According to him, the applicant has not proved the prima facie case that the patent is valid. His submission is that in the amended specification, the applicant has chosen to refer to two valves because the applicant has come to know that two spark plugs were already available in the market as it is seen in the Honda Market and it is only to get over the same, deliberately, the applicant has switched over to two valve system once again.
15(a). The learned senior counsel made it clear that in respect of Honda patent as well as AVL Licence, the respondent is a licensee relating to three valve engines. He also submit that Section 48 as amended has no meaning as long as section 13(4) makes it clear that there is no warrant about the. validity of the patent, which remains unamended and therefore, the grant of patent itself cannot be deemed to be a prima facia case on the side of the patentee and it is the duty of the patentee to prove the prima facie case as any other case of application for injunction. According to him, the third valve in the product of the respondent is not merely an ornamental, but it is functional. He would further submit that even assuming that the applicant has a patent, there is no infringement for the reason that the claim of the applicant is two valve engines and the claim of the respondent is three valve engines and two spark plugs were already used in Honda and therefore it cannot be said to be the invention of the applicant. He submits that the applicant has to prove infringement by the respondent in respect of each and every component of invention. He submits that the diameter of 45 mm. x 70 mm. is not newly invented by the applicant, because the Honda diameter is not restricted to any limitation.
15(b). His further submission is that the concept of two spark plugs is a public domain since the Honda has already invented the same in 1985. He further submits that lean burn air fuel mixture is not the object of invention. His further submission is that fuel efficiency itself cannot be an invention. He would submit that the applicant cannot rely upon newspaper report, as decided in 2007 (1) CTC 705. He submits that each and every one of the essential ingress has to be proved, based on the judgment in 1968 FSR 100. He would also rely upon the literature of Janice M. Mueller on Introduction to Patent Law wherein it is stated that each element of patent must be construed. He would also relies upon the judgment in Bishwanath Parsed Radhey Shyara v. Hindustan Metal Industries to substantiate his contention about the prior publication. His further submission is that if, in the amended specification, there is no nexus with the complete specification, it is to be deemed that the complete specification has been surrendered. He would submit that to draw a prima facie validity is different from the prima facie infringement relying upon the judgment in Franz Xaver Huemer v. New Yash Engineers , he submits that when the products, are popularly known, there is no patent and also for the purpose of proving prima facie case for injunction, he would rely upon;
(i) Monsanto Company v. Coramandal Indag Products (P) Ltd. ;
(ii) Shining Industries and Anr. v. Shri Krishna Industries ;
(iii) Hindusthan Lever Limited v. Godrej Soaps Ltd. and Ors. ; and
(iv) Niky Tasha India Private Ltd. v. Faridabad Gas Gadgets Private Ltd. AIR 1985 Delhi 136.
15(c). His further submission is that M/s. TVS Motor Company Ltd., has entered into a collaboration agreement with AVL List GMBH which is an international company known for development of engines and that collaboration was made on 13.11.2800, whereas the applicant Bajaj Auto Limited has filed its first application one year afterwards and AVL List GMBH has obtained a patent for four stroke combustion engine with at least two inlet valves on 25.5.2000 in Austria and the same has not been challenged by anyone including the applicant. He also submits that in fact, the respondent has spent enormous amount for the purpose of research and development and also it has obtained experts' opinion from various authorities from 14.9.2007 to 18.9.2007 and a certificate of registration of licence was entered between AVL List GMBH and M/s. TVS Motor Company Ltd, and it was after the statement made by the applicant, a suit for damages was filed before the Bombay High Court on 22.10.2007.
15(d). The learned senior counsel submits that while granting an order of interim injunction, the Court must satisfy itself that there is a triable issue. He would submit that once an application for revocation is filed by the respondent, it cannot be contended that prima facie case lies in favour of the applicant. He relies upon the judgment in Standipack Pvt. Ltd. v. Oswal Trading Co. Ltd. . He submits that if injunction as sought for is granted, the respondent M/s. TVS Motor Company Limited, which has manufactured the materials and also taken steps to release the same, would incur huge loss which cannot be compensated. On the other hand, according to the learned senior counsel, the applicant itself has stated that from 2003 it has manufactured the product and marketed the same and hence, based on the existing market, the compensation can be ascertained even if the injunction is not granted and in the event of the applicant winning the case finally. On the other hand, according to him, the respondent is a reputed company and its market loss cannot be determined and compensated, in the circumstances of the case. Mr. A.L. Somayaji, learned senior counsel for the respondent has referred to judgments given by various High Courts, including,
(i) Dhanpat Seth and Ors. v. Nil Kamal Plastic Crates Ltd. 2006 (33) PTC 339;
(ii) Bilcare Limited v. Supreme Industries Ltd. 2007 (34) PTC 444 (Del.);
(iii) Kalindi Medicare Pvt. Ltd. v. Intis Pharmaceuticals Ltd. and Anr. 2007(34) PTC 18;
(iv) Novartis AG v. Mehar Pharma 2005 BCR (3) 191; and
(v) Garware-Wall Ropes Ltd. v. Anant Kanoi 2006 (TLS) 216693
to substantiate his contention that as long as Section 13(4) remains unamended, the amendment of Section 48 is of no consequence and therefore, normal rule of injunction is to be followed in cases of patent also and the plaintiff must prove the balance of convenience, prima facie case etc.
16. Mr. P.S. Raman, learned senior counsel also appearing for the respondent, M/s. TVS Motor Company Ltd., apart from adopting the arguments of Mr. AL. Somayaji, learned senior counsel, would submit that he would restrict his contentions in respect of the fact that the respondent has not infringed the product of the applicant. The learned senior counsel submits that the applicant has not made out a prima facie case to the effect that the respondent has infringed the applicant's invention. His submission is that the applicant's claim is not on intrinsic components of invention and according to him, there is no invention at all and a common man knows about the product of the applicant, since it is a prior art. He submits that it is the duty of the applicant to prove that the invention was not obvious to a person skilled in the art in addition to the technical advancement or economic significance so as to establish that he has made inventive steps and in the present case, it cannot be stated that the applicant has prima facie proved that the invention is not obvious, but the fact remains that by way of prior art, the so called invention of the applicant has been known to everyone. The technical advancement or economic significance cannot be scrutinised and the meaning has to be restricted. According to him, either economic significance or technical advancement cannot be a subject matter of the patent.
16(a). He would submit that there must be nexus between the provisional specification and the complete specification and the complete specification must be based on provisional specification as per section 11 of the Patents Act so as to enable the applicant to claim priority in the matter of date of user from the date of provisional specification, viz., the date of original application. He would submit that the amended specification can be only investigative in nature which would depend upon the original specification. Therefore, according to him, if these three, viz., provisional, complete and amended specifications do not correlate to each other, the patent so granted, cannot be deemed to be a valid patent. To meet the contention of the learned senior counsel for the applicant that the respondent has never objected to the specification made by the applicant, the learned senior counsel Mr. P.S. Raman would submit that under Section 25 of the Patents Act, the question of either pre-grant, post-grant or revocation will not arise for revocation of the patent of the applicant and it can be made only when the respondent is affected. According to him, the revocation petition was filed by the respondent under Section 64 of the Patents Act, 1970 on 24.08.2007, and the applicant having taken so many adjournments before the IPAB for filing counter in the revocation petition, has chosen to file the suit for infringement after four months time.
16(b). It is his further submission that when admittedly the applicant has not even seen the product of the respondent, it is not known as to how the suit for infringement is maintainable. He would submit that the action of the respondent in filing revocation petition and thereafter launching its product would show the good conduct of the respondent which would reverse the mala fide attitude as claimed by the learned senior counsel for the applicant. He would submit that if an order of injunction is granted against the respondent which is a reputed organisation, it will create a slur on the moral conduct of the respondent and it is immaterial that injunction is granted only for three months, six months or one year, because it would impute the reputation of the respondent organisation.
16(c). He would submit that when once an application under Section 64 of the Patents Act is filed for revocation of the patent, which includes the fact that the patent of the applicant herein is not real invention, the complete specification is not a new one and it was popularly known and the complete specification does not sufficiently or fairly describe the invention, and when false suggestion is made, a presumption should be drawn that the patentee cannot have a prima facie right over the patent.
16(d). He would submit that the provisional specification dated 15.7.2082, which relates to two spark plugs and its location is admittedly a prior art, which was already available in Honda Products. He would also submit that the claim Nos. 1,6 and 7 of the applicant in the complete specification cannot be taken as an invention and if that is taken as an invention, no auto engine can be driven. According to the learned senior counsel, the claims of the applicant do not constitute any invention. He submits that US Honda 1985 was relating to three valve, 2 spark plug screw fitted engines, while AVL patent related to three valve low fuel combustion and two valve small volume motor cycles and that was already patented and. the applicant has not chosen to challenge the same. He would submit that even assuming that the applicant has got patent right, there is absolutely no infringement on the part of the respondent, as while the applicant claims two valve, the respondent claims three valves. His further submission is that the claim of the applicant that the third valve of the respondent is only non-functional and ornamental cannot be decided at this stage, since it can be decided only in the trial and in the mean time, there cannot be any presumption that the third valve is ornamental arid therefore, according to the learned Counsel, there is a total difference between the product of the applicant and that of the respondent.
16(e). He would also produce various diagrams of the engines of the applicant as well as the respondent and contend that they are totally different and the issue involved is a triable one which creates a suspicion about the patent of the applicant. According to the learned senior counsel, even if one essential element is different, there is no infringement of patent and that has to be decided at the time of trial and the balance of convenience in granting an order of injunction is not in favour of the applicant. He would submit that if the applicant succeeds in the suit, the compensation is always possible since the respondent is a very reputed organisation. His submission is that the respondent being a reputed organisation is not going to leave the country and in fact it is bound by the Motor Vehicles Act and assessable to other taxes and therefore, it is not impossible for the applicant to recover any compensation even if the applicant succeeds in the suit.
16(f). The learned senior counsel would again rely upon Section 13(4) of the Patents Act, 1970 in respect of examination and invention done and that it does not warrant any validity of patent, and therefore, relying upon the judgment in Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries , though he would submit that inference must be made prima facie, the patent is invalid on the facts and circumstances of the case. He would submit that only in cases where the defendant is not challenging the patent or revocation is not filed, the injunction will follow. On the other hand, in the present case by revocation petition under Section 64 of the Patents Act, 1970, the respondent has challenged the patent of the applicant. He would rely upon the judgment in Bilcare Limited v. Supreme Industries Ltd. 2007 (34) PTC 444 (Del.) and K. Ramu v. Adyar Ananda Bhavan Muthulakshmi Bhavan .
17. I have carefully considered the pleadings, affidavits, counter affidavits, reply affidavits, rejoinder affidavits and various documents filed by both the parties and given my anxious thought to various aspects of the case.
18. Normally, in cases of interlocutory injunction, including any patent action, the principle is the same, viz,
(i) the plaintiff must prove/show prima facie case that the patent is valid and infringed;
(ii) balance of convenience is in favour of plaintiff; and
(iii) irreparable loss that may be caused to the plaintiff by not granting an order of injunction.
19. Undoubtedly, these are the normal principles to be decided in any interlocutory injunction applications. However, the learned senior counsel appearing for the applicant Mr. C.A. Sundaram, has raised a point that after the Act 38 of 2002, by which Section 48 of the Patents Act, 1970 was amended by way of substitution, the patentees right is better protected than what was in existence in the said provision before the amendment.
According to him, after the said amendment and as Section 48 of the Patents Act, 1970 stands today, it should be treated that once a patentee files a suit for infringement based on the patent granted to him, it should be prima facie presumed to be valid until the same is revoked or set aside in the manner known to law either by revocation under any one of the grounds under Section 64 of the Patents Act, 1970 or in any other manner. Therefore, it is relevant to extract Section 48 of the Patents Act, 1970, which was in existence before the Act 38 of 2002, which came into force with effect from 20.05.2003 and the Section as it stands after the amendment. Before the amendment, Section 48 of the Patents Act, 1970 stood as follows:
Section 48. Rights of patentees.-(1) Subject to the other provisions contained in this Act, a patent granted before the commencement of this Act, shall confer on the patentee the exclusive right by himself, his agents or licensees to make, use, exercise, sell or distribute the invention in India.
(2) Subject to the other provisions contained in this Act and the conditions specified in Section 47, a patent granted after the commencement of this Act shall confer upon the patentee-
(a) Where the patent is for an article or substance, the exclusive right by himself, his agents or licensees to make, use, exercise, sell or distribute such article or substance in India;
(b) where a patent is for a method or process of manufacturing an article or substance, the exclusive right by himself, his agents or licensees to use or exercise the method or process in India.
20. After amendment with effect from 20.05.2003, Section 48 stands as on date is as follows:
Section 48. Rights of patentees.-Subject to the other provisions contained in this Act and the conditions specified in Section 47, a patent granted under this Act shall confer upon the patentee-
(a) where the subject-matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that produce in India;
(b) where the subject-matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India.
21. The difference in the said provision before the amendment and after the amendment is that before the amendment, by Act 38 of 2002, the patentee was conferred an exclusive right to use himself or through agents or through licencees and also to exercise or sell or distribute the inventions in India. The patent to which the patentee was entitled to the exclusive user related to article or substance and to a method or process of manufacturing or substance. . After amendment, the right of the patentee in respect of product and in respect of the process is conferred on the patentee, an exclusive right to prevent third parties from using or selling etc.
22. The contention of the learned senior counsel for the applicant Mr. C.A. Sundaram is that, by virtue of the amendment, the patentee's right has been enlarged not merely allowing him to the exclusive use himself, but also effectively prevent the third parties from using his patent and therefore, his submission is that, while deciding the prima facie case in granting an order of injunction pending suit, it must be taken that unless and until the patent granted to a patentee is revoked in the manner known to law, it must be presumed to be prima facie valid.
23. On the other hand, Mr. A.L. Somayaji, learned senior counsel appearing for the respondent would heavily rely upon Section 13(4) of the Patents Act, 1970, in which it is expressly made that the validity of the patent is merely because it is examined and investigated by the authority under the Act cannot be said to be warranted. His submission is that so long as Section 13(4) of the Patents Act, 1970 remains unchanged even after the amendment of Section 48 of the Patents Act, 1970, no more importance can be given to a patentee, merely because his patent has been registered. Since Section 13(4) of the Patents Act, 1970 also deals with the examination of applications for patent prescribed under Section 12, it is necessary to reproduce Sections 12 and 13 of the Act, which are as follows:
Section 12. Examination of application.-(1) [When a request for examination has been made in respect of an application for a patent in the prescribed manner [under Sub-section (1) of Sub-section (3) of Section 11B, the application and specification and other documents related thereto shall be referred at the earliest by the Controller] to an examiner for making a report to him in respect of the following matters, namely:-
(a) whether the application and the [specification and other documents relating thereto] are in accordance with the requirements of this Act and of any rules made thereunder;
(b) whether there is any lawful ground of objection to the grant of the patent under this Act in pursuance of the application;
(c) the result of investigations made under section 13; and
(d) any other matter which may be prescribed.
(2) The examiner to whom the application and the [specification and other documents relating thereto] are referred under Sub-section (1) shall ordinarily make the report to the Controller within [such period as may be prescribed].
13. Search for anticipation by previous publication and by prior claim.-
(1) The examiner to whom an application for a patent is referred under Section 12 shall make investigation for the purpose of ascertaining whether the invention so far as claimed in any claim of the complete specification-
(a) has been anticipated by publication before the date of filing of the applicant's complete specification in any specification filed in pursuance of an application for a patent made in India and dated on or after the 1st day of January,1912;
(b) is claimed in any claim of any other complete specification published on or after the date of filing of the applicant's complete specification being a specification filed in pursuance of an application for a patent made in India and dated before or claiming the priority date earlier than that date.
(2) The examiner shall, in addition, make such investigation for the purpose of ascertaining whether the invention, so far as claimed in any claim of the complete specification, has been anticipated by publication in India or elsewhere in any document other than those mentioned in Sub-section (1) before the date of filing of the applicant's complete specification.
(3) Where a complete specification is amended under the provisions of this Act before [the grant of a patent], the amended specification shall be examined and investigated in like manner as the original specification.
(4) The examination and investigations required under Section 12 and this section shall not be deemed in any way to warrant the validity of any patent, and no liability shall be incurred by the Central Government or any officer thereof by reason of, or in connection with, any such examination or investigation or any report or other proceedings consequent thereon.
24. The general tendency regarding interlocutory injunctions in patent cases has been that the onus in showing a prima facie case in justifying the grant of injunction is heavy on the plaintiff and it is comparatively easy for the defendant to establish a defence. Even though it can be contended that Section 13(4) of the Patents Act, 1970 stating that the validity of patent is not warranted is in relation to the examination of application for patent and search for anticipation made by the examiner regarding previous publication and prior claim, the effect of Section 13(4) has been clearly held by the Hon'ble Supreme Court in Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries in the following words.
33. It is noteworthy that the grant and sealing of the patent, or the decision rendered by the Controller in the case of opposition, does not guarantee the validity of the patent, which can be challenged before the High Court on various grounds in revocation or infringement proceedings. It is pertinent to note that this position, viz., the validity of a patent is not guaranteed by the grant, is now expressly provided in Section 13(4) of the Patents Act, 1970. In the light of this principle, Mr. Mehta's argument that there is a presumption in favour of the validity of the patent cannot be accepted.
25. Therefore, by virtue of the amended provision of Section 48 as stated above, one can only come to a conclusion that while deciding about the prima facie case, even though no presumption of the validity of the patent can be drawn, certainly the patent obtained after the amendment is having more significance. Therefore, the patent obtained by the patentee can be given more weight for deciding the prima facie case, however, the onus of proving prima facie case about the validity of the patent and its infringement is still on the plaintiff and the amendment to Section 48 by Act 32 of 2002 has not made any significant change on the celebrated principle of prima facie case to be proved by the plaintiff before granting an order of injunction pending disposal of the suit.
26. Therefore, we have to proceed on the basis of the materials available to decide the triple test of an interim injunction, viz., prima facie case; balance of convenience; and inadequacy of compensation.
27. Patent relates to invention or in otherwise. As per Halsbury's Laws of England, the word Patent is used denoting a monopoly right in respect of an invention.
28. Section 2(m) of the Patents Act, 1970 defines "patent" means a patent for any invention granted under this Act.
The said definition itself was substituted by the Patents (Amendment) Act, 2005 (Act 15 of 2085) with effect from 01.01.2005. Prior to the said Amendment, Section 2(m) defined "patent" as,
"patent" means a patent granted under this Act.
29. The term "invention" is defined under Section 2(j) of Patents Act, 1970 as, "invention", means a new product or process involving an inventive step and capable of industrial application.
The said definition of "invention" itself was substituted by Act 38 of 2002 and before that the said Section 2(j) stood as follows:
"invention" means any new and useful-
(i) art, process, method or manner of manufacture,
(ii) machine, apparatus or other article,
(iii) substance produced by manufacture, and includes any new and useful improvement of any of them and an alleged invention.
30. The term "inventive step" came to be defined under Act 15 of 2005 with effect from 01.01.2005 under Section 2(ja), which is as follows:
2(ja). "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
Therefore, an "inventive step" which is a necessary ingredient of invention in order to make an applicant eligible for grant of patent under the Act must be relating to an invention involving technical advance or having economic significance or both along with a necessary factor that such invention should make it "not obvious to a person skilled in the art.
31. Even though the term "obvious" has not been denied under the Patents Act, it can be safely stated to be a circumstance where a person of skill in the field, on going through the specification would complete the product. Therefore, even if any of the two ingredients, viz., technical advance or economic significance or both are available, if such invention enables a person of skill in the filed, on going through the specification would complete the product, such invention can never be treated as an "inventive step" and consequently no patent can be validly issued. Therefore, it is clear that a patent must have the characters of novelty, non-obviousness and enablement, out of which, enablement being the concept of putting the novelty into action and all the above said ingredients must consecutively be present to have a valid patent.
32. Therefore, it is clear that even after the grant of patent under Section 43 of the Patents Act, 1970, which is given effect from the date of filing of application for the patent under Section 53(1)(i), it is open to a party, who is opposing the patent to prove that there are no inventive step in the invention of a patentee and therefore, the patent granted need not be taken into consideration atleast at the stage of granting an order of interim injunction.
33. The principle objections raised by both the learned senior counsel appearing for the respondent, viz., M/s. A.L. Somayaji and P.S. Raman, is that on the factual assertions, the product of the applicant to which patent has been granted under the Act is not an invention at all. Their submission is that the applicant does not know what is its invention, since according to them different stands have been taken by the applicant on various stages before grant of patent, viz., provisional specification, complete specification and amended specification made by the applicant. Therefore, it is relevant to point out factually about the prima facie validity of the patent claimed by the applicant in the sense of non-contradiction in its stand to decide about the interim injunction.
34. The applicant made the application along with the provisional specification under the Patents Act for the issuance of patent on 16.07.2002; the applicant has made the complete specification on 07.07.2003; the amended specification was made by the applicant on 08.11.2004; and ultimately, the patent was granted on 29.07.2005 in Patent No. 195904. It is not in dispute that the patent granted in the above patent number to the applicant is deemed to have come into effect from the date of its application, viz., provisional specification dated 16.07.2002.
35. By applying Sections 11(2) and 11(3) of the Patents Act, 1970 to the facts of the case, prima facie, there is no difficulty to come to the conclusion that the applicant has launched the product in 2003 on complete specification, which was on 07.07.2003, and therefore, that may 'be taken as the actual priority date of the claim of complete specification.
36. For the purpose of deciding the prima facie case, it is relevant to refer to the provisional specification, complete specification and amended specification submitted by the applicant/plaintiff in the light of the submissions made by the respective counsel.
37. Under the provisional specification submitted by the applicant on 16.07.2002, the applicant has made it clear that its invention relates to improvement in the combustion characteristics of a single cylinder internal combustion engine working on 4 stroke principle, and stated that the said invention, particularly relates to engines employed as prime movers for operation of 2 and 3 wheeled vehicles, after explaining various disadvantages of engines provided with two valves with a spark plug and the location of spark plug tip, velocity of the charge, the direction of swirl which are decided as important parameters stated to be the known methods of improvement.
38. The provisional specification further states that the disadvantages explained are due to use of only one spark plug in the combustion resulting in loss of power, fuel wastage, increase in emission and there was need of a richer mixture of fuel and air in the charge in achieving better drivability results. It is stated in nutshell as follows:
In order to avoid above difficulties and to provide improved combustion characteristics for lean air fuel mixture burning, we have invented an engine, wherein there are two spark plugs provided for generating the spark. These spark plugs are located in the cylinder head one on timing chain side and the other plug being opposite to the timing chain side.
(a) The provisional specification also states,
In order to have the spark plug on the timing chain side and to prevent the above disadvantage, we have developed a design and an arrangement wherein the plug is located on the same side of the timing chain by providing a replaceable sleeve, which encompasses the spark plug.
(b) By providing two spark plugs, the initiation of the spark starts at two places, i.e. Tips (21a & 22a) in the combustion chamber. These places are diametrically opposite to each other. Due to this, the flame propagates faster and covers the entire volume comparatively in shorter time and thus achieving near complete combustion of the lean air fuel mixture. This reduced time of achieving near complete combustion permits use of a leaner mixture helping saving of fuel without affecting performance.
(c) Ultimately, the specification concludes as follows:
It is will be appreciated that the invented engine with improved combustion characteristics for lean air fuel mixture burning as described and illustrated in the drawings that it would be possible to modify and/or alter the various features thereof by person skilled in the art without deviating from the scope of the invention. The applicant intends to include those modifications and variations within the scope and the ambit of this invention.
39. Under the complete specification submitted by the applicant on 07.07.2003, the applicant specifically explains that its invention is relating to small displacement engines of cubic capacity ranging from 75 to 250 CC preferably 100 to 200 CC per cylinder employed, as under:
This invention relates to improvement in the combustion characteristics of an internal combustion engine working on 4 stroke principle. This invention particularly relates to small displacement engines of cubic capacity ranging from 75 to 250 cc preferably 100 to 200 CC per cylinder employed as prime movers for operation of 2 and 3 wheeled vehicles. Internal combustion engine wherever referred to in this specification means and includes either single cylinder or its duplication thereof.
(a) The concept of 2 spark plugs which was available in the provisional specification is also explained in detail in the complete specification, which is as follows:
In order to avoid above difficulty and provide for improved combustion characteristics through rapid completion of the combustion even with a lean air fuel mixture, we have invented an engine wherein there are two spark plugs provided for generating sparks at two predetermined locations at the same time. These spark plugs are located in the cylinder head one on timing chain side and the other plug opposite to the timing chain side. Thus, the twin spark plug arrangement enables the engine to run efficiently which results in decreased emission, decreased fuel consumption and good drivability.
(b) The provision of 2 spark plugs is again explained as under:
By providing two spark plugs, the initiation of the spark starts at two places i.e. Tips (21a. & 22a) in the combustion chamber. These places are opposite to each other. Due to this the combustion is completed in a comparatively shorter duration of time leading to reduction in emission and improved fuel consumption while maintaining the desired level of performance. This reduced time of achieving near complete combustion permits use of less amount of fuel air mixture or lean mixture without affecting the performance for the same power out put, especially at part throttle condition.
(c) Ultimately, in claim Nos. 1 and 6 of the complete specification, the applicant has explained about its invention, as under:
1. An improved Internal Combustion Engine for efficient burning of lean air fuel mixture used. in engines working on four stroke principle, characterised in that said Internal Combustion Engine comprising a pair of spark plugs (21 & 22), a cylinder head (25), a sleeve (23), a pair of sealing means (24 & 24a), a fixing means (26) and sleeve cap (27); the said pair of spark plugs (21 & 22) being fitted to the said cylinder head (25) to ignite air fuel mixture at predetermined instant; said spark plug (22) being housed within said sleeve (23), said sleeve (23), being detachably fixed to the said cylinder head (25) and held in position by said fixing means (26), said sealing means (24 & 24a) being provided between the said cylinder head (25) and the outer periphery of the said sleeve (23) and the said sleeve cap (27) being fitted on to said sleeve (23).
6. An improved Internal Combustion working on four stroke principle, characterised in that said Internal Combustion Engines comprising of a spark plugs (22), a cylinder head 925), a sleeve (23), a pair of sealing means (24 and 24a), a fixing means (26) and sleeve cap (27); the said spark plug (22) being housed within said sleeve (23) and being fitted to the said cylinder head (25) on timing chain side (7) so as to provide spark at predetermined instant to ignite air fuel mixture; the said sleeve (23) being detachably fixed to said cylinder head (25) and held in- position by said fixing means (26), the said pair ,of sealing means (24 & 24a) being provided between the said cylinder head (25) and the outer periphery of the said sleeve (23) and the said sleeve cap (27), made of resilient material such as Nylon, PVS, rubber being fitted on said cylinder head (25).
40. In the amended specification dated 08.11.2004, 'the applicant makes it clear that the invention particularly relates to small displacement engines and in explanation of the complete specification dated 07.07.2003. The said amended part of the specification is as follows:
This invention particularly relates to small displacement engines of swept cylinder volume ranging from 75 cc to 225 cc and cylinder bore diameter 45 mm to 70 mm, preferably in the range of 100 cc to 200 cc, employed as prime movers for operation of 2 and 3 wheeled vehicles or other motorized vehicles. For the simplicity of explanation, such engines are termed as 'engines' in the subsequent paragraphs in this specification.
(a) The applicant has also referred to about the Honda patent in existence and explained as to how the specification of the applicant is in contrast to the same.
Use of two spark plugs in an engine with 3 valves and of relatively larger bore diameter (more than 70 mm) is known, eg. As described in US Patent No. 4534322 A1. In the engines with 3 valves, the space restriction in the cylinder head does not provide an optimum place for the spark plug (ideally to be mounted centrally) and it is necessary to adopt two spark plugs to achieve proper combustion even with the normal mixture ratios. Use of two spark plugs for an engine with only two valves is therefore not normally necessitated from space constrains. Further more, as the bore size (and therefore the swept volume) of a cylinder increases the flame propagation distance increases and therefore the use of twin spark plugs becomes a consideration. In contrast, it is counterintuitive to consider the use of twin spark plugs in a small bore cylinder; application as the flame propagation distance is not normally an issue that arises in conventional engines.
(b) The activity of the 2 spark plug has also been explained in the amended specification along with the research conducted on 05.11.2004, which is as follows:
By providing two spark plugs, the initiation of the spark starts at two places, i.e. Tips (21a& 22a) in the combustion chamber. These places are diametrically opposite to each other. Due to this, the combustion is completed in a comparatively shorter duration of time leading to reduction in emission and improved fuel consumption while maintaining the predetermined level of performance. This reduced time of achieving near complete combustion permits use of less amount of fuel air mixture or lean mixture without affecting the performance, especially at part throttle condition.
The applicants have developed in two valve, per cylinder 150 cc capacity engines with invented features of this application and the same has been evaluated. The table given below indicates the comparative test values of the engines with and without the invented feature. The emission values are as tested with statutorily applicable Indian Driving Cycle on Chassis dynamometer.
Test results conducted on a 150 cc engine.
No.
Parameters
Single Spark Plug Configuration
Twin Spark Plug Configuration
1
CO mass emission (g/km)
1
0.6
2
HC mass Emission (g/km)
0.7
0.5
3
Nox mass omission (g/km)
0.5
0.5
4
Fuel consumption (km/1)
55
62
5
Max power (Ps)
11.7
12.5
(c) Again Claim Nos. 1,6 and 7 in the amended claim of the applicant are as follows:
1. An improved Internal Combustion Engine working on four stroke principle, having two valves per cylinder for efficient burning of lean air fuel mixture used in engines where the diameter of cylinder bore ranges between 45 mm and 70 mm characterised in that said Internal Combustion Engine comprises a pair of spark plugs, namely a first spark plug (21) and a second spark plug (22), a cylinder head (25), a sleeve cup (27), said first and second spark plugs (21 and 22) being fitted to said cylinder head (25) and capable of igniting air fuel mixture at predetermined instant; said second spark plug (22)n being housed within said sleeve (23) located within timing chain cavity; said sleeve (23) being detachably push fitted to said cylinder head (25) and held in position by said fixing means (26), said sealing means (24, 241) being adapted between said cylinder head (25) and the outer periphery of said sleeve (23) and said sleeve cap (27) being fitted on said cylinder head (25).
6. An improved Internal Combustion Engine working on four stroke principle, having two valves per cylinder, for efficient burning of lean air fuel mixture used in engines wherein the diameter of cylinder bore ranges between 45 mm and 70 mm characterised in that said Internal Combustion Engine comprises a spark plug (22), a cylinder head (25); a sleeve- (23), a pair of sealing means (24,24a), fixing means (26) and a sleeve cap (27); said spark plug (22) being fitted to said cylinder head (25) and capable of igniting air fuel mixture at predetermined instant; said spark plug (22) being*housed within said sleeve (23) located within timing chain cavity; said sleeve (23) being detachably push fitted to said cylinder head (25) and held in position by said ' fixing means (26),,said sealing means (24, 24a) being adapted between said cylinder head (25) and the outer periphery of said sleeve (23), and said sleeve cap (27) being fitted on said cylinder head (25).
7. An improved single cylinder Internal Combustion Engine working on four stroke principle having two valves for efficient burning of lean air fuel mixture used in engines wherein the diameter of said cylinder bore ranges between 45 mm and 7 5 mm substantially as herein described and as illustrated in the drawings accompanying the Specification.
41. The main contention of Mr. A.L. Somayaji, learned senior counsel for the respondent is that the applicant, in its specification, is not certain about its invention stating that in the provisional specification the claim of the applicant was spark plug centered while in the complete specification it has become valve centered and ultimately in the amended specification it is stated as spark plug centered. He has also stated that in the amended specification the applicant has chosen to state for the first time about the diameter of cylinder bore as ranging from 45 mm to 70 mm which was not available in the previous specifications.
42. I am afraid that factually the same may not be correct. Even though in the provisional specification the applicant has not specifically explained the diameter of the cylinder, it was its specific case that the invention, particularly relates to engine prime mover for operation of 2 and 3 wheeled vehicles. This was subsequently explained by the applicant in its complete specification dated 87.87.2003 that "this invention particularly relates to small displacement engines of cubic capacity ranging from 75 to 250 CC preferably 100 to 200 CC per cylinder employed as prima movers for operation of 2 and 2 wheeled vehicles" and therefore, the applicant has chosen to explain the importance of 2 spark plugs with lean burn air fuel mixture, etc. That was again the claim made by the applicant in the amended specification on (28.11.2004. In fact, in the amended specification the applicant has referred to US Patent No. 4534322, which relates to use of 2 spark plugs in an engine with three valves with relatively larger diameter more than 70 mm.
43. In fact, a reference to the description of US Patent regarding Honda, as produced by the respondent, while explaining about the disadvantages of a 3 valve engine, shows that it has-less performance than a 4 valve cylinder head above 7000 rpm; big bore (>70 mm) only works well with twin spark. Therefore, even as per the Honda specification, which is stated to have been followed by the respondent it is admitted that more than 70 mm is deemed to be big bore and on the basis of the record, it cannot be said at least at the prima facie stage that there is any deviation in the specification made by the applicant in these three stages.
44. In this regard it is relevant to note that a final claim cannot be invalidated merely, because it gives more construction than what was available earlier during the time of provisional specification. That was the view taken along with establishing the right of fair and reasonable monopoly on the part of a patentee in Muto Industrial Company Limited's Application 1978 RPC 70. The relevant portion of the judgment is as follows:
The criteria fundamental to fair basis are set out in Mond Nickel Co. Ltd.'s Application [1956] R.P.C. 189 and I.C.I. Ltd.'s Patent [I960] R.P.C.223 but the application of the three tests there propounded is commented on in Letraset Ltd. v. Rexel Ltd. [1974] R.P.C. 175 at 196 where it is stated that the decision on fair basis "must be directed to giving the patentee a fair and reasonable monopoly having regard to his disclosure and at the same time to ensure that, as for example by the manipulation of dates, the public are not improperly prejudiced. The cases cited provide a useful test which can be applied, but must I think always be read with this general intention in mind." In the case of Letraset's patent, the provisional specification described the transfer of indicia from a carrier sheet to a sheet to be coated by rubbing with a stylus or other hard object whereas the complete specification referred in the claims to detachment of the indicia from the carrier sheet "by local stretching .... by application of pressure to the back surface of the carrier sheet". It was held that the feature of stretch release was not inconsistent with the disclosure of the provisional and indeed it was a result that necessarily followed from the disclosure of the provisional specification; nor did it matter that the provisional specification did not mention such results specifically.
That was also the view in Patent Exploitation Ld. v. Siemens Berothers & Co. Ltd. 1903 RPC 225, wherein the Court 'of Appeal has held as follows:
A Patentee's rights are defined by his Specification and claim. The Plaintiffs cannot supplement their Letters Patent by proving that the batteries as in fact made under their Letters Patent show invention and invention of such a character as to constitute good subject - matter. But, on the other hand, it is important when the Court comes to construe the Plaintiffs' Specification, to look and see whether the Plaintiffs' battery in so far as it exhibits novelty constitutes a useful invention, and in making this inquiry the Court should have regard to the past history of the subject-matter of the Patent, which is in this case galvanic batteries, and should have regard to the past history of the subject-matter of the Patent, which is in this case galvanic batteries > and should have regard to the recognised deficiencies of galvanic batteries upto date and to the utility of the Plaintiff's battery in meeting those deficiencies as evidenced by the adoption of that battery in the market and in daily use to the exclusion largely of its predecessors. And the Court should have, in my opinion, regard also in construing a Specification to common knowledge up to date. If the Court finds that the Plaintiffs' battery as made meets a recognised deficiency then if the Specification is capable of more constructions than one, including a construction which will read the Specification as defining a battery such as that which has attained a practical success, the Court will be . astute to adopt that construction, and in order to do so, will not hesitate to reject even the natural construction of words on the ground that such natural construction so inconsistent with up to date common knowledge that it is impossible that the Patentee could have used the words in question in their mere natural sense.
It was held in Sandow Ld. v. Szalay 1906 RPC 6 that the provisional specification is to ascertain and describe the nature of invention while the complete specification may also explain in what manner the invention is to be carried out in execution and therefore, either in a complete specification or amended specification, if an explanation is made to a provisional explanation, it cannot be said as if the patentee has abandoned a part of his claim. The relevant portion of the judgment of the House of Lord Macnaghten, Lord Robertson and Lord Lindley is as follows:
My Lords, I venture to think that that is perfectly correct and I must protest against the proposition which was in effect laid down by the learned Lords Justices that you are to compare the Complete Specification with the Provisional Specification, and if you find something dropped out you are to come to the conclusion that it has been deliberately abandoned. I think that is not paying due attention to what the office and purpose of the Provisional Specification is. The purpose of the Provisional Specification is to ascertain and describe the nature of the invention. But the Complete Specification must ascertain and particularly describe the nature of the invention and also in what manner it is to be carried into execution. My Lords, I think that in this case in the Complete Specification the Patentee has ascertained and described the nature of the invention and sufficiently pointed out how it is to be carried into execution, and I think that the Defendant, the Respondent in this case, has infringed the Patent.
45. The next aspect to be considered is about the product of the applicant, which has been patented and its value. It is the specific case of the applicant that the product invented by it is not known earlier and the invention is having economic significance, apart from not being "obvious". Ever since the date of provisional specification, which was on 16.07.2002 and even after the applicant has introduced the product, viz., Bajaj Pulsar motor cycle in the open market in1 the year 2003, the respondent has not raised objection at any point of time and the applicant has in fact stated that in the year 2003-2004, the share of "DTS-i Technology", which is the invention patented in this case in respect of Bajaj Pulsar was 9.8%/ which got increased in the year 2004-2005 to 26.98%; in 2005-2006 to 36.54%; 2006-2007 to 38.96% and 2007-2008 (April-November) 54.25%. In such circumstances, there is no difficulty to come to the conclusion that prima facie the product of the applicant for which the patent was granted as invention has found a special place in the market.
46. On the other hand, it is the clear conduct of the respondent, who has not objected to the product of the applicant ever since the year the patent application was made in 2002, has chosen to file a revocation petition under Section 64 of the Patents Act, 1970 before the IPAB, challenging the patent granted to the applicant for the first time on 24.08.2007. It is also significant to note that immediately within six days from the date of filing of the revocation petition, the respondent has chosen to introduce its products, including 125-CC motor cycle called "FLAME". This certainly cannot be taken as a bona fide conduct of the respondent, by looking into the over all factual situation in this case.
47. The patent granted to the applicant relates back to the date of application, viz., 16.07.2002 or in any event from the date of introduction of the product by the applicant, viz., Bajaj Pulsar "DTS-i Technology", which was in the year 2003 and the same is valid for a period of 20 years as per the provisions of the Patents Act, 1970. By referring to the amendment introduced by Act 38 of 2002, it was held in K. Ramu v. Adyar Ananda Bhavan Muthulakshmi Bhavan 2007 (34) PTC 689 by S. Rajeswaran, J. that when issuance of a patent right is an admitted fact and the same is valid for a period of 20 years, the plaintiff is deemed to have discharged its initial responsibility of proving that they are protected by the certificate issued by the competent authorities under the Patents Act and therefore, it should be presumed to be a prima facie case on the strength of the certificate. The operative portion of the judgment is as follows:
16. It is an admitted fact that the Plaintiff has been issued with patent rights for both process and product. The process is for preparation of low glycemic sweets for a term of twenty years from 13th February, 2003. Similarly, they are also entitled to patent for the product for twenty years from July, 2004. Thus, the plaintiff has discharged his initial responsibility by proving that they are protected by the certificate issued by the authorities under the Patents Act, 1970. In-other words, the Plaintiffs have established a prima facie case on the strength of their two certificates. In such circumstances, Section 48 of the Patents Act, 1970 will hold the field according to which a patent granted under, this Act shall confer upon the patentee, the exclusive right to prevent third parties from the act of making , using, selling or importing that product in India if the subject matter of the patent is a product. Similarly, if the subject matter of the patent is a process, the patentee has the exclusive right to prevent third parties from the act of using the process for sale, selling for those purpose the product obtained directly by that process in India. Therefore, the plaintiff having obtained the patent for both the process and product under the Patent Act, 1970 has got the statutory right to prevent third parties from infringing those rights.
17. When third parties infringe the rights granted under the Patent Act then Section 108 of the Act will come into operation according to which, in case of infringement the Court may grant the reliefs including injunction and ordering the goods to be seized, forfeited or destroyed.
48. While it is true that after the amendment, there is a significant change, nevertheless, as I have stated above, it is the duty of the plaintiff to prove the prima facie case, balance of convenience and irreparable injury in the event of not granting interlocutory injunction. The three imminent factors which are necessary for consideration while dealing with the issue of interim injunction during pendency of legal proceedings are stated by the Division Bench of this Court in Wockhardt Ltd. v. Hetero Drugs Ltd. and Ors. 2006 (32) PTC 65 (Madras), wherein by relying upon the observation of the Supreme Court, the Division Bench has laid down the principles to be followed while granting an order of interim injunction as under:
16. The above observations of the Supreme Court would make it clear that the following guidelines have to be taken into consideration, while dealing with the issue of grant of an interlocutory injunction during the pendency of legal proceedings, which require the exercise of the discretion of the Court. While exercising the said discretion, the Court applies the following tests:
(a) Whether the plaintiff has a prima facie case;
(b) Whether the balance of convenience is in favour of the plaintiff; and
(c) Whether. the plaintiff would suffer an irreparable injury, if his prayer for interlocutory injunction is disallowed.
17. Relief by way of interlocutory injunction is granted to mitigate the risk of injustice to the Plaintiff during the period before that uncertainty could be resolved. The object of the interlocutory injunction is to protect to plaintiff against injury by violation of his right for which he could not be adequately compensated in damages recoverable in the action if the uncertainty were resolved in his favour at the trial.
Applying the said principles to the facts I have stated above, adding to the conduct of the respondent, there is no difficulty to come to the conclusion that the applicant has proved the prima facie case in its favour in respect of the patent granted to its product.
49. As far as the revocation application filed by the respondent under Section 64 of the Patents Act, 1970, it cannot be said that by mere filing of such application, presumption should be drawn against the validity of patent, while it is true that the grant of patent itself will not certify the validity of the same. As it is incorporated under Section 13(4) of the Patents Act, 1970. Certainly, under Section 64 of the Patents Act, when a revocation petition is filed under anyone of the grounds stated therein, the same can be operative only after a final decision is rendered by the authority competent to decide the same and in the meantime, it cannot be said that the patent validly granted should be presumed to be suspicious. The validity or otherwise of the patent depends upon the complexity of issues involved while arriving at a conclusion as to whether there has been an inventive step or as to whether the invention of the patentee was a prior art or whether it was obvious that the person possessed of average skill or average knowledge of the art to which the invention relates and on going through the specification would be able to accomplish, or whether there was a false suggestion or representation; these are all matters involving complexity of trial and at this stage it is only the prima facie view which can be taken into consideration.
50. The fact that the patent creates a statutory monopoly, of course, protects the patentee against any unlicensed user of the patented devise enabling the patentee to get an order of injunction, and considering that a patent has been in existence for more than 5 years, the patentee must be treated as actual user and there is a presumption of its validity. In this connection it is relevant to refer to the judgment of a Division Bench of Delhi High Court in Telemecanique & Controls (I) Ltd. v. Schneider Electric Industries SA 2002 (24) PTC 632 (Del) wherein it has been held as follows:
29. Mr. Mukul Rohatgi, learned Counsel for the respondent, has also relied upon National Research Development Corporation of India, New Delhi v. The Delhi Cloth and General Mills Co. Ltd. and Ors. AIR 1980 Delhi 132, to contend that if the patents are more than 6 years old and there has been actual user, there must be presumption of validity of patent. In the present case the patents have existed unchallenged for a period of 8 years. It has been further contended by Mr. Rohatgi that it is not required in case of a violation of the patent that the person violating the patent knew about it in view of the monopoly having been created in favour of the appellant.
30. It has to be appreciated that undoubtedly patent creates a statutory monopoly protecting the patentee against any unlicensed user of the patented device. Thus once a violation is established in case of a registered patent, subject of course, to the patent being used, it will not be permissible to contend that the said patentee is not entitled to an injunction. A monopoly of the patent is the reward of the inventor. It is also to be appreciated that law of the patent is slightly different from the law of copyright and trademark as the patent is granted only for a period of 14 years....
Applying the said yardstick in the present case, it is not in dispute that from 2003 till date the applicant has been marketing its products, which has been patented with "DTS-i Technology" and the same has obtained a significant place in the market, since the number of products sold by the applicant throughout the world in these years is steadily increasing and the same has not been denied with any material and therefore, certainly the applicant has proved the prima facie case in its favour.
51. Now coming to the question of infringement, it is not in much dispute that except the use of three valves, the product which is attempted to be marketed by the respondent is prima facie similar to the applicant's patented product. In this regard, the applicant has chosen to state with great emphasis that the third valve which has been included by the respondent in its product is of no action or otherwise is stated to be cosmetic in nature because both the applicant's patent as well as the respondent's TVS "FLAME" motor-cycle are relating to internal combustion engine, working on 4 stroke principle with the diameter of bore ranging from 45 mm to 70 mm, two spark plugs for lean burn, etc. The respondent, who claims to have adopted either Honda patent or AVL patent which is the licensor of the respondent, has chosen to have the diameter of the bore as 54.4 mm, which is certainly not a large engine, but a small engine. In the context of the applicant's specific statement in the plaint as well as in the application for interim injunction that the third valve used by the respondent has no material effect on the applicant's invention, it is a matter of evidence, which can be decided only after full-fledged trial.
52. In this regard, it is relevant to refer to a judgment of English Court in Court of Appeal in William Needham and James Kite v. Johnson and Co. 1884 JRPC 49. While referring to the variant aspect, the Court has held as follows:
Then arises the question whether, if that is the claim, the Defendants have infringed it, have infringed the combination. They have infringed it sif they have used that combination. If they have used that combination, and also something added to it, that combination remaining a necessary part of their machine, but the addition to it being an improvement, and if they have used that, but without acknowledgement, that is to say, without acknowledgement that they are only using an improvement, that would be an infringement, no doubt. If they had invented such a machine as I have described, . they would have been entitled to take out a patent, not for that machine as a new machine, but for an improvement upon the Plaintiffs' machine. If they had claimed the improvement on the Plaintiffs' machine, they could not use their improved machine without paying the proper price to the Plaintiffs for having used their machine although improved. If they used it without paying, they would infringe.
Therefore, it is clear that the defence of variant must be real and essential to the features and purpose of plaintiff's product.
53. While deciding the test for variant raised as a defence by the defendant, the three questions have been raised and answered by the English Court in Improver Corporation and Ors. v. Remington Consumer Products Ltd. and Ors. 1990 FSR 181, which are as follows:
The proper approach to the interpretation of patents registered under the Patents Act 1949 was explained by Lord Diplock in Catnic Components Ltd. v. Hill & Smith Ltd. The language should be given a "purposive" and not necessarily a literal construction. If the issue was whether a feature embodied in an alleged infringement which fell outside the primary, literal or a contextual meaning of a descriptive word or phrase in the claim ("a variant") was nevertheless within its language as properly interpreted, the court should ask itself the following three questions:
(1) Does the variant have a material effect upon the way the invention works? If yes;, the variant is outside the claim. If no -
(2) Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent- to a reader skilled in the art. If no, the variant is outside the claim. If yes -
(3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention. If yes, the variant is outside the claim.
54. It is also clear as per the decisions, for the purpose of deciding the novel features to constitute "pith and marrow" a purposive construction has to be given in order to make it essential requirement of the invention that any variant would follow outside the monopoly even if it could not have material effect upon the working of invention. That was the view taken by the House of Lords in Catnic Components Ltd. and Anr. v. Hill & Smith Ltd. 1982 RPC 183. Their Lordships have explored the legal issue in that regard as follows:
My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. "skilled in the art"), by which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called "pith and marrow" of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.
55. The effect of patent granted under the Act and its consequential user apart from a third person using the patented product in the substance equivalent to the patented article has been dealt with by the Division Bench of Delhi High Court in Raj Prakash v. Mangat Ram Choudhary and Ors. , which is as follows:
24. The effect of the grant of a patent is quid pro quo. Quid is the knowledge disclosed to the public and quo is the monopoly granted for the term of the patent. Section 12 of the Patents and Designs Act, 1911 sets out that a patent once granted confers on the patentee the exclusive privilege of making, selling and using the invention throughout India and of authorising others so to do. This is the quo. The quid is compliance with the various provisions resulting in the grant of the patent. The very simple device upheld in John Lord Hinde v. Osborne Garrett and Co. 1884 (1) R.P.C 221, and an infringing hair-pin was held as piracy of the plaintiff's invention with the following observations:-
The inventor says, I ask you, the public or rather I ask the Crown, to give me a monopoly for a certain number of years and in consideration of their giving me that monopoly I will tell them in my specification the nature and manner of using the invention. I claim, and therefore at the expiration of the time that is guaranteed for my monopoly the public will be the gainers because they will learn how to do this. If a man obtains a patent, and thus obtains a monopoly, it makes no difference that somebody else who has not got a patent has thought of the same thing and has used it. He is not permitted to do that where the monopoly has been secured to an inventor.
This law is codified in India by the provisions already referred to.
25. The patented article or where there is a process, then the process, has to be compared with the infringing article or process to find out whether the patent has been infringed. This is the simplest way and indeed the only sure way to find out whether there is piracy. This is what was done in the hair - pin case above referred to, and is indeed always done. Unessential features in an infringing article or process are of no account, If the infringing goods are made with the same object in view which is attained by the patented article then a minor variation does not mean that there is no piracy. A person is guilty of infringement if he makes what is in substance the equivalent of the patented article. Some trifling or unessential variation has to be ignored. There is a catena of authority in support of this view. We need not cite all those cases which were brought to our notice at the Bar. Suffice it to quote the words of Lord Denning, M.R. In Beecham Group Ltd. v. Bristol Laboratories Ltd. 1967 R.P.C 406:-
The evidence here shows that in making hetacillin in the United-States the defendants use a principal part of the processes which are protected here by the English patents. The importation and sale here is prima facie an infringement.
There is a further point. A person is guilty of infringement if he makes what is in substance the equivalent of the patented article. He cannot get out of it by some trifling or unessential variation..... On the evidence as it stands, there is ground for saying that hetacillin is medically equivalent to ampicillin. As soon as it is put into the human body, it does, after an interval, by delayed action, have the same effect as ampicillin. In these circumstances, I think there is a prima facie case for saying there was an infringement. The process is so similar and the product so equivalent that it is in substance the same as ampicillin.
Therefore, it is clear that the applicant has made out a prima facie case for injunction against the respondent.
56. Now, coming to the next point to be decided in the interlocutory application, viz., balance of convenience, the first ingredient is about the use of the patent by the applicant and the respondent. It is true that in cases where the use of the applicant's patent is recent in origin or the patentee has not even used or commenced to release its product, then such patentee is not entitled for the grant of injunction.
57. While considering about the grant of interim injunction under Order XXXIX Rule 1 and 2 of Code of Civil Procedure, in the light of the Designs Act, 1911, a Full Bench of the Delhi High Court in Metro Plastic Industries (Regd.) v. Galaxy Footwear, Delhi AIR 2000 Del. 177 FB, has considered the Division Bench judgment in Niky Tasha India Private Ltd. v. Faridabad Gas Gadgets Private Ltd. AIR 1985 Delhi 136, where the Division Bench held that every ground on which a design may be cancelled under the Act should be available by way of defence to a suit for infringement and that on the strength of a recent design, the plaintiff can claim absolute restrain against everyone else from carrying on his business unless and until the plaintiff's design is cancelled in appropriate proceedings by the competent court of law and Another. Division Bench judgment of the Calcutta High Court in Rotomac Pens Ltd. v. Milap Chand & Co. IPLR 1999 April, 149, wherein the Division Bench of the Calcutta High Court while dealing with the Designs Act has held, comparing the Indian and English laws on the subject that Section 53 of the Designs Act gives statutory right to a registered owner to sue for protection of his exclusive right, finally held that even if a registered design is of recent in nature, Section 53 of Designs Act confers a power on the proprietor to restrain others unlike in UK. Ultimately, the Full Bench of the Delhi High Court has not accepted both the above decisions, by harmoniously construing Sections 51 and 53 of the Designs Act, in the following words:
33. Therefore, in our view, neither the extreme view taken in Nicky Tasha's case or in Rotomac Pen's case are correct.
58. In Bilcare Limited v. Supreme Industries Ltd. 2007 (34) PTC 444 (Del), the Delhi High Court, while deciding on a patent regarding issuance of temporary injunction under Order XXXIX Rule 1 and 2 of Code of Civil Procedure, has held that use of a patent for two years cannot be said to be sufficiently old as follows:
25. After assessing the pros and cons of these cases the following factors emerge. The patent in question is new one. It was registered in the year 2004. The appellants filed the suit in the year 2006, i.e., after the lapse of two years only. By no stretch of imagination it can be said to be sufficiently old. There are no conflictions on the point that the patent is less than six years old. Secondly, there are tangible grounds for suspicion of the alleged invention. There lies no rub in granting damages which would provide an adequate remedy should the claim succeed. Above all it will not be proper to upset the well reasoned judgment of the trial court at this stage. The trial court has meticulously checked the record with precision and clarity. All the three essential conditions viz, prima facie case, balance of convenience and irreparable loss lean on the side of the respondents.
59. However, as I have stated above, in the present case, the applicant's patent has been in use from 2003, nearly five years and the applicant has sold 126335 Bajaj 2 Wheelers with "DTS-i Technology" in 2003-2004; 431712 in 2004-2005; 741441 in 2005-2006; 934935 in 2006-2007; and 814393 in 2007-2008 upto November, 2007 and therefore, it cannot be said that the applicant's use of the patented product is of recent in nature.
60. That apart, prima facie it can be held safely that it has achieved economic significance as one of the ingredients of the term "inventive step" under Section 2(ja) of the Patents Act, 1970, especially when the factum of sale of such large number of products is not under dispute.
61. The test of balance of convenience has been aptly explained by the Court of Appeal in Corruplast Ltd. v. George Harrison (Agencies) Ltd. 1978 RPC 761 as follows:
In so regarding the matter, in my opinion the learned judge was taking too narrow a view upon the question of balance of convenience. If the plaintiffs are right about infringement, they are entitled to be protected by their patents against competition by the defendants until those patents expire. They are struggling to establish a new market and to establish themselves in that market; they are, or they appear to be, at a crucial stage of that development, and if the defendants are allowed to compete with the plaintiffs, not only will the plaintiffs' present efforts be hindered, but also at the expiry of their patents, when other competitors may come on the market as well as the defendants, they will find that instead of being the only known and established suppliers in this country, they will have to compete with the defendants, who may by then have built a significant bridgehead in the market, giving them an advantage over other suppliers, and the plaintiff company will find itself confronted by stronger competition than would otherwise be the case.
...
...In every case of this kind the function of the court must, I think, be to consider which course, either the granting or withholding of an injunction, is the one which is likely to make it most easy for the trial court, when the issues in the action have been decided, to adjust the rights of the parties and do justice between them; and in the present case it seems to me that the balance of convenience is substantially in favour of granting an injunction.
Therefore, prima facie when it is made clear that the applicant/plaintiff is in the market and its patent is for a limited period and it is in a crucial stage of development, the respondent/defendant cannot be permitted to interfere, especially when the defendant is a strong competitor to the plaintiff.
62. More over, on the factual position in this case, the applicant has come up in the world market by sale of its product as stated above and its period is only for 20 years and there is every possibility for a new invention in the field by bringing the new product even before the time of expiry of patent granted to the applicant and such invention may be brought by the applicant itself and hence, the quantum of damages which the applicant may suffer in not granting injunction cannot be ascertained in monetary sense. On the other hand, the respondent claiming itself to be a licensor of AVL products has not even marketed its product. On the face of the validity of the patent, prima facie proved by the applicant, certainly, the applicant is entitled to prevent any competition and that is the test of balance of convenience as laid down by the English Court as stated above.
63. At this stage, it is relevant to point out one other judgment of the Bombay High Court in Farbweke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning a Corporation etc. v. Unichem Laboratories and Ors. , wherein it is held that when a person
challenges the validity of patent, the onus is on him to prove against its validity. The relevant portion of the judgment is as follows:
13. From what is discussed in the preceding paragraph it will therefore, be clear that the main heads of the alleged invalidity of the plaintiffs' patent on which the defendants rely by way of defence are only four viz., (1) insufficiency of description; (2) want of novelty; (3) no inventive step and (4) want of utility. It may be stated that the onus in regard to all objections to validity lies on the defendant (Halsbury, (3rd ed. ) Vol.29 p.106 paragraph 218). I shall now proceed to deal with each of those grounds.
64. In the context of the facts and situation of the present case, I am of the considered view that the contention that triable issues against the patent must be found out by the Court before granting an order of injunction is not sustainable, in the light of the amended provision of Section 48 of the. Patents Act, 1970 (Amended Act 38 of 2002 with effect from 20.05.2803), by which a patentee is given a exclusive right to prevent third parties from using its patent and product.
65. It is relevant, as correctly pointed out by the learned senior counsel for the applicant, to find out the reason for such change in the legal position, which can be culled out from the Statement of Objects and Reasons for the said Amendment Act 38 of 2002, which has come into effect from 20.05.2003. The Statement of Objects^ and Reasons refers to the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and states that one of the salient features of the said Bill was to,
(c) to align rights of patentee as per Article 28 of the TRIPS Agreement;
The relevant portion of the Objects and Reasons in this regard is,
The law relating to patents is contained in the Patents Act, 1970 which came into force on the 20th April, 1972. The Act was last amended in March, 1999 to meet India's obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which forms part of the Agreement establishing the World Trade Organisation (WTO). Apart from the aforesaid amendment, the Act has not undergone any change so far. Since 1972, there has been considerable technological innovations and development of knowledge and the concept of intellectual property as a resource for knowledge based industries has become well recognised the world over. Development of technological capability in India, coupled with the need for integrating the intellectual property system with international practices and intellectual property regimes, requires that the Act be modified into a modern, harmonised and user-friendly legislation to adequately protect national and public interests while simultaneously meeting India's international obligations under the TRIPS Agreement which are to be fulfilled by 31st December, 1999.
Keeping in view the Statement of Objects and Reasons stated above and also the salient features of the Bill, Section 48 has been amended to give better rights to the patentees and the entire aspect has to be looked into in that angle also. Since the purpose is the concept of globalisation and for the development of the " intellectual property system in India on par with international practice, such rights are given. On the other hand, the triable issue against patent sought to be raised on behalf of the respondent is that the specifications in various stages differ and therefore, the applicant itself is not aware of its invention, which prima facie I have found as not correct. In such factual situation, the question of raising a triable issue against the patent granted to the applicant at this stage does not arise.
66. It is also relevant to refer to the judgment of the Court of Appeal in Monsanto Company v. Stauffer Chemical Company 1984 FSR 574, wherein the Court of Appeal, while holding that the trial Court will answer the question of, infringement on different materials untrammelled by the tentative views expressed on interlocutory application, has held, on the concept of payment of compensation in the event of granting injunction and " not granting injunction in the interlocutory application, as follows:
We find Mr. Gatwick's submissions, noticed above, very cogent on the material which is before us, and we have no doubt that the plaintiffs amply discharge the onus that is on them of showing that (as Falconer J. held) there is a serious question to be tried on infringement. At the trial there will no doubt be much fuller exposition in evidence and by cross examination of the chemical aspects of the case, and of the extent of knowledge of the skilled reader at the relevant date. The trial judge will therefore have to answer the question of infringement on different material, untrammelled by any tentative views expressed on this interlocutory application.
We turn to the matter of balance of convenience.
What has to be considered first under this heading is whether, if the plaintiffs were to succeed at the trial in establishing their right to a permanent injunction, they would be adequately compensated by an award of damages for the loss they would have sustained between the time of this present application and the time of the trial. What has next to be considered is whether, on the contrary hypothesis that the defendants were to succeed at the trial in establishing their right to do what is sought to be enjoined, they would be adequately compensated under the plaintiffs' undertaking as to damages for the loss they would have sustained by being prevented from doing so between the present time and the time of the trial. It is not in dispute that in the present case each side is well able to pay any damages which may be awarded against it.
Therefore, the second aspect of grant of interim injunction-, viz., the balance of convenience is also in favour of the applicant for granting an order of injunction.
67. The last and final test regarding the grant of interim injunction is about the payment of damages, whether the same can compensate the parties while granting or not granting an interlocutory order of injunction.
68. As I have stated earlier, the test is as to whether the plaintiff should be made to face the adverse effect of competition. Further, a contention was raised by the learned Counsel for the respondent in these applications, viz., that the applicant is capable of being ascertained with an amount of calculated damages, with reasonable certainty, ultimately when the applicant succeeds in the suit, since the amount of applicant's sales will be known and the sales in the previous year can be taken into consideration for the purpose of measurement of damages to be quantified on royalty basis. A similar contention was rejected by the Court of Appeal in Netlon v. Bridport-Gundry Ltd. 1979 FSR 530. While granting injunction at the appellate stage, the Court of Appeal has answered as follows:
I must now proceed to consider the question of damages. The respondents say that any damage that the appellants would suffer by not obtaining an injunction, if they ultimately prove right at the trial, is capable of being calculated with reasonable certainty and so damages are an adequate remedy. They say that the amount of the respondent's sales will be known, so also will those of Netlon in previous years, so that the measure of the diminution of business as the result of their activities can be ascertained and the damages quantified by calculation on a royalty basis. For my part, I am unable to accept this argument. The first year would be a building-up one so that one would have to look at least to the second, but then, I think, it would be impossible * to distinguish sales due to the early start with the assistance of the patented material and sales which the respondents would have made anyway. The truth, in my judgment, is that it is quite impossible to calculate the adverse effect upon the appellants of their having to face competition a year-earlier than they would have to do if the respondents had to wait for supplies of unquestionably unoffending material.
69. The further plea of the respondent that the patent given to the applicant is "obvious", since the components explained by the applicant are known to the entire world and there is no specialty in the invention of, the applicant, is also not acceptable, especially at this interlocutory stage. In Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries the Supreme Court observed that
under Section 13(4) of the Patents Act, 1970, the validity of a patent is not guaranteed and the same can be challenged. While dealing about the concept of "inventive step" the Supreme Court held that it is a mixed question of law and fact to decide about the novelty or subject matter. It also explained the concept of "obvious" and held that a patented invention may be a combination of different matters already known, but it must be something more than a mere workshop improvement. The object of patent law has been very aptly explained by the Hon'ble Supreme Court in the following words:
17. The object of Patent Law is to encourage scientific research, new technology and industrial progress. Grant of exclusive privilege to own, use or sell the method or the product patented for a limited period, stimulates new inventions of commercial utility. The price of the grant of the monopoly is the disclosure of the invention at the Patent Office, which, after the expiry of the fixed period of the monopoly, passes into the public domain.
18. The fundamental principle of Patent Law is that a patent is granted only for an invention which must be new and useful. That is to say, it must have novelty and utility. It is essential for the validity of a patent that it must be the inventor's own discovery as opposed to mere verification of what was already known before the date of the patent.
19. "Invention" means any manner' of new manufacture and includes an improvement and an allied invention". (Section 2 (8) of 1911 Act). It is to be noted that unlike the Patents Act 1970 the Act of 1911 does not specify the requirement of being useful in the definition of 'invention'. But Courts have always taken the view that a patentable invention, apart from being a new manufacture must also be useful. The foundation for this judicial interpretation is to be found in the fact that Section 26(1) (f) of the 1911 Act recognised lack of utility as one of the grounds on which a patent can be revoked.
20. ...
21. It is important to bear in mind that in order to be patentable an improvement on something known before or a combination of different matters already known, should be something more than a mere workshop improvement; and must independently satisfy the test of invention or an "inventive step". To be patentable the improvement or the combination must produce a new result, or a new article or a better or cheaper article than before. The combination of- old known integers may be so combined that by their working interrelation they produce a new process or improved result. Mere collection of more than one integers or things, not involving the exercise of any inventive faculty, does not qualify for the grant of a patent. 'It is not enough' said Lord Davey in Rickmann v. Thierry 1896-14 RPC 105 (HL) 'that the purpose is new or that there is novelty in the application, so that the article produced is in that sense new, but there must be novelty in the mode of application. By that, I understand that in adopting the old contrivance to the new purpose, there must be difficulties to be overcome, requiring what is called invention, or there may be some ingenuity in the mode of making the adoption'. As Cotton L.J. Put in Blakey and Co. v. Lathem and Co. (1889) 6 RPC 184 (CA), "to be new in the patent sense, the novelty must show invention". In other words, in order to be patentable, the new subject matter must involve 'invention' over what is old. Determination of this question, which in reality is a crucial test, has been one of the most difficult aspects of patent law, and has led to considerable conflict of judicial opinions.
22. ...
23. ...
24. Whether an alleged invention involves novelty and an 'inventive step' is a mixed question of law and fact, depending largely on the circumstances of the case. Although no absolute test uniformly applicable in all circumstances can be devised, certain broad criteria can be indicated, whether the "manner of manufacture" patented, was publicly known, used and practised in the country before or at the date of the patent? If the answer to this question is 'Yes', it will negative novelty or 'subject-matter1. Prior public knowledge of the alleged invention which would disqualify the grant of a patent can be by word of mouth or by publication through books or other media. "If the public once becomes possessed of an invention", says Hindmarch on Patents (quoted with approval by Fry L.J. In Humpherson v. Syer 1887-4 RPC 407 "by any means whatsoever, no subsequent patent for it can be granted either to the true or first inventor himself or any other person: for the public cannot be deprived of the right to use the invention.......... the public already possessing everything that he could give".
25. The expression "does not involve any inventive step" used in Section 26(1) (e) of the Act and its equivalent word "obvious", have acquired special significance in the terminology of Patent Law. The 'obviousness' has to be strictly and objectively judged. For the determination several forms of the question have been suggested. The one suggested by Salmond L.J. In Rado v. John Tye and Son Ltd. (1967) RPC 297, is appositel. It is:
Whether the alleged discovery lies so much out of the Track of what was known before as not naturally to suggest itself to a person thinking on the subject, it must not be the obvious or natural suggestion of what was previously known.
26. Another test of whether a document is a publication which would negative existence of novelty or an "inventive step" is suggested, as under:
Had the document been placed in the hands of a competent draftsman (or engineer as distinguished from a mere artisan), endowed with the common general knowledge at the 'priority date', who was faced with the problem solved by the patentee but without knowledge of the patented invention, would he have said, "this gives me what I want?" (Encyclopaedia Britannica; ibid). To put it in another form: "was it for practical purposes obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention the subject of the claim concerned?" Halsbury, 3rd Edn., Vol. 29, p. 42 referred to by Vimadalal J. of Bombay High Court in Farbwerke Hoechst and B. Corporation v. Unichem Laboratories .
70. The usability of the patented product in the manner of anticipation as one of the basic concept of novelty has been explained by the Privy Council in Pope Appliance Corporation v. Spanish River Pulp and Paper Mills Ltd. AIR 1929 PC 38, as follows:
The test of anticipation has been dealt with in many cases. They were enumerated in the very recent case of British Thomson Houston Co. v. Metropolitan Vickers Electrical Co. (2). At p.23 the judgment runs thus:-
In Otto v. Linford (3) at p. 44, Lord Justice Holker expresses himself thus: 'We have it declared in Hill v. Evans as the law, and it seems very reasonable, that the specification which is relied upon as an anticipation of the invention must give you the same knowledge as the specification of the invention itself.' And in Flour Oxydising Co. v. Carr & Co. (4), Mr. Justice Parker (afterwards Lord Parker) says: 'When the question is solely a question of prior publication, it is not, in my opinion, enough, to prove that the apparatus described in an earlier specification could be made to produce this or that result. It must also be shown that the specification contains clear and unmistakable directions so to use it. ' And the remarks of Lord Dunedin in Armstrong Whitworth & Co. v. Hardcastle (5), are quite in line with these dicta.
In the same case the test is stated at p.22, and turning the particular instance to the general may be expressed thus - Would a man who was grappling with the problems solved by the patent attacked, and having no knowledge of that patent, if he had had the alleged anticipation in his hand have said, "That gives me what I wish?"
71. In any event, the test of "obviousness" which forms part of the term "inventive step" under Section 2(ja) of the Patents Act, 1970 will have to be decided only in an appropriate manner in a full-fledged trial. Suffice it to say now at this stage, prima facie there is novelty which means an invention and the same has been registered under the Patents Act with priority date and the enablement of novelty has been on the face of it proved by the applicant by marketing the product in such large extent and also without objection fairly for long 5 years and it is not proved that so far the product of the applicant is "obvious". I am therefore of the considered view that the concepts of prima facie case, balance of convenience and inadequacy of damages lean largely towards the applicant/plaintiff and the necessary conclusion can only be the grant of injunction in favour of the applicant/plaintiff.
72. I have taken into consideration while arriving at such conclusion the novelty stated to have been achieved by the applicant by way of patent, coupled with its enablement, as proved by putting the product in the market and that has earned usage in large extent and both novelty and enablement have been established by the applicant for the purpose of granting the order of injunction in favour of the applicant/plaintiff.
73. In view of the same, interim injunction as prayed for in O.A. No. 1357 of 2007 in C.S. No. 1111 of 2007, is granted. Accordingly, O.A. No. 1357 of 2007 in CS. No. 1111 of 2007 stands allowed. Consequently, O.A. No. 1272 of 2007 in C.S. No. 979 of 2007, stands dismissed. There will be no order as to costs.
prabhakar singh
(Expert) 13 October 2011
Bilcare Limited vs The Supreme Industries Ltd. ... on 20 March, 2007
Equivalent citations: MIPR 2007 (2) 13, 2007 (34) PTC 444 Del
Author: J Malik
Bench: J Malik
JUDGMENT
J.M. Malik, J.
Page 0929
1. This order shall decide the two appeals mentioned above which entail similar questions of facts and law. The controversy in these two appeals swirls around the question, "is there any presumption in favor of the validity of the patent for grant of temporary injunction in favor of patentee." The present appeals are directed against the orders of the learned Trial Court dated 7th February, 2007, wherein the Trial Court dismissed the applications under Order XXXIX Rules 1 and 2 CPC filed by the plaintiff/appellant, the applications filed by the defendants/ respondents under Order XXXIX Rule 4 CPC were permitted and ex parte injunction orders dated 6th October, 2006 were vacated. However, the defendants/respondents were directed to maintain accounts of the sales they make of the impugned product. Page 0930 The defendants/respondents were also directed to submit the statement of accounts after every three months in the court and to submit undertakings that they would pay the damages to the plaintiff/appellant in case the plaintiff subsequently succeeds in this case. It was also observed that the respondents had already filed opposition to the patent before the concerned authorities but the impugned order would not in any way affect the decision of the concerned patent authorities regarding the disposal of opposition. However, during the arguments advanced before this Court, it transpired that above said opposition to the patent was filed only by one of the two respondents i.e. M/s Associated Capsules Pvt. Ltd.
2. The appellant's case is this. It has been manufacturing and marketing blister films made out of a variety of plastic materials including PVC for packing pharmaceutical products since 1997. The main drawback of PVC films is that these allow moisture to pass through these and therefore cannot be used for medicines, which are even slightly sensitive to moisture, like vitamin tablets, analgesics like Paracetamol with Nimuselide, Antibiotics and Antibiotic combinations like Tetracycline, Amoxycilin etc. For all these drugs, there was a need to use more expensive multi-layered films, which are sometimes as high as three times the cost of PVC film or else use aluminum foils, which are even more expensive. The main idea was to protect the medicine from moisture. The appellant developed a process and a film was made using that process, by depositing a fine layer of aluminum on the surface of the PVC film. The said film had good moisture barrier properties and could protect sensitive medicines from moisture. It had unique property that it was translucent and therefore the medicine tablets and capsules could be easily identified by patients and the trade. This metallized translucent PVC film for pharmaceutical use was the first of its kind in the world. The film was invented in the year 2004 and a patent application was filed under No. 262/MUM/2004, dated 3rd March, 2004, at the Indian Patent Office. The application was accepted and no opposition was received within the statutory time. The said application was granted registration at serial number 197823. The said patent was also granted to the appellant in the United States of America. The scope of patent of 197823 was set out primarily in claim No. 1 which runs as follows:
(i) A multi-layer thermoformable, translucent pharmaceutical and food packaging film consisting of a core layer of 100 to 1000 microns thickness of food grade poly vinylchloride(PVC), devoid of plasticizers having vinylmonomer less than 1 ppm and a global migration of additives less than 60 ppm; and a metallized layer of thickness 0.02 to 2 microns provided at least on one side of the said core layer and at least one to 250 microns thick food and pharmaceutical grade polymeric layer provided at least on one side of the core layer.
3. The defendants/respondents were found to be manufacturing and marketing 2 and 3-layered PVC metallized film, and thereby infringing the appellant's registered patent. The plaintiff/appellant thought that it had a bone to pick with the respondents and as such it filed two separate suits against each of the respondents Under Section 48, 104 and 108 of the Patents Act for restraining respondents from infringing the patent No. 197823 and Page 0931 rendition of accounts. Applications under Order 39 Rules 1 and 2 CPC were also filed along with the Suits. The ADJ in his ex-parte order restrained the respondents from manufacturing, marketing, selling, utilizing, buying, offering for sale or importing any metallized PVC pharmaceutical packaging film that infringes the Appellant's patent No. 197823 on 6th October, 2006.
4. The respondents contested the above said applications and moved applications under Order 39 Rule 4 CPC for vacation of ex-parte injunction orders granted vide order dated 6th October, 2006. The respondents enumerated the following defenses.
5. It was pointed out that opposition had already been filed by one of the respondents against the patent before the Patent Office, Mumbai. The patent is invalid and open to challenge on all grounds of lack of inventive step, public knowledge, prior art, wrongful obtaining and lack of novelty. The resistance to moisture and translucency upon thermoforming are prior art in the industry, the multi-layered film has been in vogue for over 10 years. The appellant's/plaintiff's alleged invention is of at least a three layered film while the defendants'/respondents' product is a two-layered film. The plaintiff/appellant got patent registered by claiming an invention which is already in public knowledge and has been used prior to the filing of its patent application. The respondents are aware of the drawbacks of PVC film with respect to its permeability to moisture and multi-layered options/aluminium foils used in the pharmaceutical packing. The plaintiff's patent in India is for a multi-layered as against a two-layered film. The defendants' product does not infringe the appellant's patent being a two-layered film. The appellant has expressly disclaimed a two-layered film during its US patent application process by stating before the United States Patents and Trademark Office that its invention applies to at least a three-layered film as a two-layered film has been patented as long back as 1975 in the US by an inventor, Akao. The various properties set out in claim No. 1 of the complete specification are known in the industry or being prior art, as such no monopoly or exclusivity can be claimed by the plaintiff; the two and three layered composite films comprising PVC core layer, aluminium metalic layer and PVdC topcoat having the same thickness is known in the prior art.
6. I have heard the counsel for the parties at a considerable length. The learned Counsel for the appellant argued with vehemence that the appellant has proved that (i) it has a prima facie case (ii) the balance of convenience lies in its favor, and (iii) it would suffer irreparable injury if injunction is not granted. He has drawn my attention towards Sections 11A, 25, 43, 48, 64, 107, 108, 131 and 135 of the Patents Act, 1970. In order to buttress his arguments, he has cited the following authorities.
7. In Dalpat Kumar and Anr. v. Prahlad Singh and Ors. , it was held:
The phrases "prima facie case", "balance of convenience" and "irreparable loss" are not rhetoric phrases for incantation, but words of width and Page 0932 elasticity, to meet myriad situations presented by men's ingenuity in given facts and circumstances, but always is hedged with sound exercise of judicial discretion to meet the ends of justice. The facts are eloquent and speak for themselves. It is well nigh impossible to find from facts prima facie case and balance of convenience. The respondents can be adequately compensated on their success.
8. In Anand Prasad Agarwalla v. Tarkeshwar Prasad and Ors. , it was observed:
It may not be appropriate for any court to hold a mini-trial at the stage of grant of temporary injunction.
9. Giridhari Balaram Radhakrishnani and Anr. v. Mahisa Electronics and Ors. , was a case under the Patents Act. It was held:
10. The concept of the grant of interlocutory injunctions has been considered in American Cynamid Co. v. Ethicon Ltd. (supra) 2nd 1976 Karnataka 426. Therefore, we will only refer to the principles referred thereto which read:
(i) There is no rule that a plaintiff must make out a prima facie case. " The court no doubt must be satisfied that the claim is not frivolous or vexatious; in other words, that there is a serious issue to be tried".... So unless the material available to the court at the hearing of the application for an interlocutory injunction fails to disclose that the plaintiff has any real prospect of succeeding in his claim for a permanent injunction that the trial, the court should go on to consider whether the balance of convenience lies in favor of granting or refusing the interlocutory relief that is sought.
(ii) It is no part of court's function at this stage of the litigation to try to resolve conflicts of evidence on affidavit as to facts on which the claims of either party may ultimately depend nor to decide difficult questions of law which call for detailed agreement and mature considerations.
13...
It is also notice in that decision that as a rule of prudence if the patent is a new one a mere challenge at the bar would be sufficient for refusal of the temporary injunction, but if the patent is sufficient old and has been worked, the court would, for the purpose of a temporary injunction, presume the patent to be a valid one and indicate that the period of six years of actual use of the patent would give rise to such presumption.
15. The learned Judge noticed that no temporary injunction could be granted when the patent is a recent one and its validity is questioned. But the two questions to be considered in this case were as contended for the appellants that prima facie case as stated by the House of Lords in American Cyanamid Company's case should have been taken note of and examined the matter. Although, at one time the law as to the concept Page 0933 of prima facie case depended on various factors, now the predominant factor is that the appellants have a case to go for trial. In fact, the learned Judge noticed this position but declined to examine the question by securing a technical opinion in relation to the prima facie validity of the patent and prima facie infringement thereof on the ground that when the main issue to be decided in the case is the very question to be decided in the interim application, trial is the best process to be adopted. That means, in the view of the learned Judge there was a case to go for the trial. If there is a case to go for trial, obviously there is a prima facie case in terms of the language adopted by the American Cyanamid Co. case and that law has been approved by the Supreme Court in several decisions. Even otherwise, if the principles laid down in 52 Calcutta Weekly Note 253 are to be adopted none of the factors explained thereof has been taken note of by the learned Judge. Above all, in matters of this nature when two rival parties are contending for their respective rights to exploit the market in relation to certain goods by manufacturing the same and when one party is precluded to put forward a new product, in granting or refusal of injunction in such cases various factors have to be balanced by analysing the decision in American Cyanamid Company's case. Thus, we are of the view, with great respect to the learned single Judge that he should have taken note of the fact whether prima facie case is established or not in terms of the principles in 52 Calcutta Weekly Notes 253 or in terms of the decision in American Cyanamid Company's case and also the factor that if either injunction is granted in favor of the appellants whether they should be put on terms to make good damages by offering appropriate security or depositing money or ultimately if the appellants succeed, the matter may have to go for accounting and to safeguard the interest of the appellants, respondents should be put on terms for refusal of injunction. If such process is not adopted, justice cannot be done to either party.
10. In K. Ramu v. Adyar Ananda Bhavan and Muthulakshmi Bhavan O.A. Nos. 535 and 536 of 2006 in C.S. No. 495 of 2006 (Madras High Court), it was observed:
It is an admitted fact that the Plaintiff has been issued with patent rights for both process and product. The process is for preparation of low glycemic sweets for a term of 20 years from 13.2.2003. Similarly they are also entitled to patent for the product for 20 years from July 2004. Thus the plaintiff has discharged his initial responsibility by proving that they are protected by the certificate issued by the authorities under the Patents Act 1970. In other words the plaintiffs have established a prima facie case on the strength of their two certificates. In such circumstances Section 48 of the Patents Act, 1970 will hold the field according to which a patent granted under this Act shall confer upon the patentee the exclusive right to prevent third parties from the Act of making, using, selling or importing that product in India if the subject matter of the patent is a product. Similarly if the subject matter of the patent is a process the patentee has the exclusive right to prevent 3rd parties from the act of using the process for sale, selling for those purpose the product obtained directly by that process in India.
Page 0934
11. In Ajay Industrial Corporation v. Shiro Kanao of Ibaraki City AIR 1983 Delhi 496, it was held,
It was observed in Lallubhai Chakubhai v. Chimanlal & Co. AIR 1936 Bom 99:
A new and useful application of an old principle may be good subject-matter. An improvement on something known may also afford subject-matter; so also a different combination of matters already known. A patentable combination is one in which the component elements are so combined as to produce a new result or arrive at an old result in a better or more expeditious or more economical manner. If the result produced by the combination is either a new article or a better or cheaper article than before, the combination may afford subject-matter of a patent.
12. In Metro Plastic Industries (Regd.) v. Galaxy Footwear, New Delhi , it was held that merely because a registration is recent, is by itself no ground for refusing an injunction. It was further held that that also would be a factor which could be taken into consideration by the Court.
13. I find force in the arguments urged by learned Counsel for the appellant in a measure but it cannot be made a rule of thumb that interlocutory injunction must be granted whenever a case is filed in this context. Other following factors are to be considered:
(i) Whether the Act in question is really an invention. It is to be proved that the device in question is new, non-obvious and inventive.
(ii) Whether it is not of recent origin?
(iii) Whether it pertains to three-layered product or two-layered product?
(iv) And uppermost, whether the damages will provide adequate remedy should the claim succeed?
(v). Last but not the least, whether it will be proper for the appellate court to upset the trial court order which has made perspicacious judgment?
All these knotty questions must be investigated or discussed down to the ground. If the answers are hidden behind the veil of impenetrable mystery or these are apparent from the materials available, injunction ought not to be granted. It is trite saying that it is nobody else but the appellant himself, who, is to carry the ball in proving its case. Let us examine these questions in view of literature and other authorities.
14. The respondents have drawn the attention of this Court towards a book titled as "Packaging Foods with Plastics" written by Wilmer A. Jenkins and James P. Harrington, which also finds a mention in the order of the learned trial court. This book was published in the year 1991. This book must be read in juxta position with the alleged invention made by the appellant. This book deals with various subjects/topics, including Impermeability to Oxygen and Water Vapor, Control of Packaging, Atmosphere, Odor Protection, Light Control and Packing appearance, metal coating, low temperature flexibility, thermo plastics, multi layer films, thermoforming, etc. (between pages 7 to 23). Page 0935 Under the head of Multi Layer Films at page 19, at the foot of the page it is clearly , specifically and unequivocally mentioned:
that probably the first use of coextrusion was to provide a glossy surface of crystal polystyrene to the dull finish of high impact polystyrene. Although the typical coextruded film or sheet only has three to seven layers, there have been operations where as many as eleven layers have been used.
15. A comparative study of this book and the scope of patent No. 197823 set out primarily in claim No. 1 has put a large question mark over the so called invention. An integument of doubt envelops the case of the appellant. This is a very intricate matter which requires evidence of experts, investigation and other evidence.
16. In Bishwanath Prasad Radhey Shyam v. H.M. Industries AIR 1989 SC 1444, it was held,
18. The fundamental principle of Patent Law is that a patent is granted only for an invention which must be new and useful. That is to say, it must have novelty and utility. It is essential for the validity of a patent that it must be the inventor's own discovery as opposed to mere verification of what was already known before the date of the patent.
xxx
21...
To be patentable the improvement or the combination, must produce a new result, or a new article or a better or cheaper article than before. The combination of old known integers may be so combined that by their working inter-relation they produce a new process or improved result. Mere collection of more than one integers or things, not involving the exercise of any inventive faculty does not qualify for the grant of a patent. It is not enough said Lord Davey in Rickmann v. Thierry 1896-14 RPC 105 (HL) that the purpose is new or that there is novelty in the application so that the article produced is in that sense new, but there must be novelty in the mode of application. By that , I understand that in adopting the old contrivance to the new purpose, there must be difficulties to be overcome requiring what is called invention, or there may be some ingenuity in the mode of making the adoption'. As Cotton L.J. put in Blakey and Co. v. Lathem and Co. (1889) 6 RPC 184 (CA), "to be new in the patent sense, the novelty must show invention." In other words, in order to be patentable the new subject matter must involve 'invention' over what is old. Determination of this question, which in reality is a crucial test has been one of the most difficult aspects of patent law, and has led to considerable conflict of judicial opinions. xxxxx
33. It is noteworthy that the grant and sealing of the patent or the decision rendered by the Controller in the case of opposition, does not guarantee the validity of the patent, which can be challenged before the High Court on various grounds in revocation or infringement proceedings. It is pertinent Page 0936 to note that this position viz. the validity of a patent is not guaranteed by the grant, is now expressly provided in Section 13(4) of the Patents Act, 1970. In the light of this principle, Mr. Mehta's argument that there is a presumption in favor of the validity of the patent cannot be accepted.
xxx
51. In our opinion the findings of the learned trial Judge to the effect that the patent is not a manner of new manufacture or improvement, nor does it involve any inventive step having regard to what was known or used prior to the date of patent, should not have been lightly disturbed by the Appellate Bench.
17. In Dhanpat Seth and Ors. v. Nil Kamal Plastic Crates Ltd. 2006 (33) PTC 339 (HP), it was observed,
12...
In support of this argument, he placed reliance upon American Cyanamid Co. v. Ethicon Ltd. (1975) 1 All ER 504.
13. The precedent, relied upon by the learned Counsel, is of no avail to the plaintiffs/petitioners for the simple reason that the statutory law prevailing in India is contrary to the law laid down therein. Section 13(4) of the Patents Act, 1970 says that the validity of the patent is not warranted by the grant. The Hon'ble Supreme Court in Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries , has held as follows, vide para 33 at page 1450 (already cited above).
18. In Monsanto Company v. Coramandal India Products (P) Ltd. it has been held that to satisfy the requirement of being publicly known as under in Clauses (e) and (f) of Section 64(1) of the Patents Act, 1970, it is not necessary that it should be widely used to the knowledge of the consumer public. It is sufficient if it is known to the persons who are engaged in the pursuit of the knowledge of the patented product or process either as men of science or men of commerce or consumers. The section of the public who, as men of science or men of commerce, were interested in knowing about herbicides which could destroy weeds but not rice, must have been aware of the discovery of the active agent. There was no secret about the active agent as claimed by the plaintiffs since there was no patent for the agent. The process was known, the product was known, the use was known and then there was no invention.
19. In Ram Narain Kher v. Ambassador Industries New Delhi and Anr. , it was observed:
When an invention is not itself new, the particular use of it for the purpose described in combination with the other elements of the system producing the advantageous results would be a sufficient element of novelty to support the Patent and in a claim for Patent pertaining to air cooler the claimant must specify what particular features of his device distinguish it from those which had gone before and show the nature of Page 0937 the improvement which is said to constitute the invention and the claim that there would be 25 per cent additional advantage of added cooled air by fixing the fan at the top of the cooler than in the customary way hitherto known in the front of the cooler must be succinctly stated in the claim before the Patent authority and must not be left to an inference raised on a general review of the specification. (Head note)
20. In Standipack Pvt. Ltd. and Anr. v. Oswal Trading Co. Ltd. etc. it was held,
15. It has been held in a series of judgments that no presumption of validity attaches to a patent granted by the Controller under the Act notwithstanding examination and investigation made under Sections 12 and 13. In this connection reference may be made to a decision in Bishwanath Prasad v. Hindustan Metal Industries , Hindustan Lever Ltd. v. Godrej Soaps Ltd. and Niky Tasha India Pvt. Ltd. v.
Faridabad Gas Gadgets Pvt. Ltd. Reported in AIR 1985 Delhi 136 at
138. In Surendra Lal Mahendra v. Jain Glazers reported in 2nd 1981 (1) Delhi 257, the Delhi High Court relying upon the judgment in Smith v. Grigg Ltd. (1924) 41 RPC 149 (1), held that despite all the safeguards and circumspection contemplated in various provisions of the Act against grant of patent in respect of a spurious, purloined or fake invention, the Legislature minced no words in clarifying its intendment that no presumption of validity would attach to a patent granted by the Controller under the Act, notwithstanding examination and investigation made under Sections 12 and 13 thereof.
xxx
16...
It is settled law that in an action for infringement of a patent an injunction would not be granted where the validity of the patent itself has been questioned and a revocation petition has been filed. In this connection reference may be made to a decision of the Madras High Court in V. Manicka Thevar v. Star Plough Works , wherein it was held that if from the objections raised by the defendant it is clear that a serious controversy exists as to whether or not the invention involves any new inventive skill having regard to what was known or used prior to the date of the patent; courts would not grant an injunction restraining the defendant from pursuing his normal business activity. It was also held that an interim injunction would not be granted if the defendant disputes the validity of the grant. In Niky Tasha India Pvt. Ltd. v. Faridabad Gas Gadgets Pvt. Ltd. AIR 1985 Delhi 136 at 140 (supra) it was observed by this Court that no injunction should be granted when there is a serious question of the validity of the design to be tried in the suit and an application for cancellation has been made.
xxx
Page 0938
11...
Thus the plaintiff relies upon and claims the right of patent in respect of the thickness of the films that have been used in the manufacture of the pouches. It may, however, be noted that thickness of the plastic film/layer depends upon the tolerance of the contents of the pouch. Thus the same is merely an arrangement and re-arrangement of the mixture of the material and cannot be termed as a novel concept and does not have any novelty. Such arrangement and re-arrangement of mixture of the material cannot become an invention, for it is only an improvement by adding microns as per the strength of the layers. Thus prima facie the invention claimed by the plaintiff in respect of the thickness of the layers of the aforesaid pouch cannot be called an invention as envisaged within the definition clause of the Patents Act. Besides the documentary evidence placed on record prima facie indicates that the claim made by the plaintiff is already known in the trade and patent was published.
21. In National Research Development Corporation of India, New Delhi v. The Delhi Cloth and General Mills Co. Ltd. and Ors. AIR 1980 Delhi 132, it was observed:
It is also a rule of practice that if a patent is a new one, a mere challenge at the bar would be quite sufficient for a refusal of a temporary injunction but if the patent is sufficiently old and has been worked the court would for the purpose of temporary injunction, presume the patent to be valid one. If the patent is more than 6 years old and there has been actual user it would be safe for the court to proceed upon this presumption.
22. The observation made in Niky Tasha India Private Ltd. v. Faridabad Gas Gadgets Private Ltd. AIR 1985 Delhi 136, neatly dovetails with the above said views. It was held,
It is well settled, both in India and in England, that an interlocutory injunction will not normally be granted where damages will provide an adequate remedy should the claim succeed. Furthermore, the Court will not grant an interlocutory injunction unless satisfied that there is a real probability of the plaintiff succeeding on the trial of the suit.
23. In Hindustan Lever Ltd. v. Godrej Soaps Limited and Ors. 1997 PTC (17) 756, it was held,
24...
In patent cases the onus of showing a prima facie case justifying the grant of an injunction is a heavy one and it is comparatively easy for the respondent to establish a defense sufficient to prevent the grant of such an injunction in Hubbard and Anr. v. Vosper and Anr. (1972) 1 All ER 1023 at 1029, Lord Denning observed : "In considering whether to grant an interlocutory injunction, the right course for a Judge is to look at the whole case. He must have regard not only to the strength of the claimant but also to the strength, of the defense, and then decide what is best to be done. Sometimes, it is best to grant an injunction so as to maintain the status quo until the trial. At other times, it is best not to impose a restraint on the defendant, but leave him free to go ahead. For Page 0939 instance, in Frazer v. Evans (1969) 1 All ER 8, although the plaintiff owned the copyright, we did not grant an injunction, because the defendant might have a defense of fair dealing. The remedy by interlocutory injunction is so useful that it should be kept flexible and discretionary. It must not be made the subject of strict rules.
xxx
28. Mr. Chakraborty, learned Counsel has submitted that in view of the above decision of the House of Lords, the view taken by a Division Bench of this Court in Boots Pure Drug Co. v. May and Baker Ltd. 1948 (52) CWN 253 should be taken as not laying down the correct principle of law. In that case, it was held that in order to get a temporary injunction against the infringement of a patent right, it is necessary that the plaintiffs should prove three things:
(a) that they have a prima facie, that is to say, they have such evidence as would lead the Court to come to the conclusion that the patent is prima facie a valid patent;
(b) they must prove by prima facie evidence that there has been an infringement on the part of the defendant; and
(c) that the balance of convenience is in favor of the plaintiffs.
29. As regards condition (a) it is a rule of practice (emphasis added) that if a patent is a new one, a mere challenge at the Bar would be quite sufficient for the refusal of a temporary injunction, but if the patent is sufficiently old and has been worked, the Court would, for the purpose of a temporary injunction, presume the patent to be a valid one. If the patent is more than 6 years old and there has been actual user it would be safe for the Court to proceed upon this presumption.
xxx
48. Mr. Mukerjee has also referred to the following passage at pp.113 of Brain C. Reid's "A. Practical Guide to Patent Law" 2nd Edition (1993):
Nevertheless, the grant of interlocutory relief is by no means automatic; it remains, at the end of the day, an exceptional remedy given at the Court's direction for which exceptional cause to be shown. The leading modern decision in this area of the law generally, American Cyanamid v. Ethico (Interlocutory was in fact enunciated in a patent dispute in 1974.)
49. But the learned author at pp.116 of same treaties has drawn the attention to the danger inherent in mechanical application of the American Cyanamic approach; "In particular, the Court will not allow the American Cyanamic approach (which in principle is quite favorable to the patentee) to become by over-rigid application an engine of oppression. This is highlighted by the decision of the Court of Appeal in Brupat v. Sandfod Maston Products 1983 RPC 61 where a defendant of extremely modest financial standing (normally a good reason for grant of relief since it gives rise to doubt as to their eventual capacity to pay damages if infringement is found at the trial) was allowed to continue provided that he pay in the interim into an escrow account a reasonably royalty.
Page 0940
24. Now I turn to one more significant aspect. The order passed by learned trial court appears to be flawless. In a case reported in Telemecanique and Controls(I) Limited v. Schneider Electric Industries SA 2002 I AD (DELHI) 451, it was held,
It is appropriate to observe at this stage before considering the rival contentions advanced on behalf of learned Counsel for the parties that this appeal has to be decided within the parameters laid down by the Supreme Court in the case of Wander Limited and Anr. v. Antox India P. Ltd. 1990 (supp) SCC 727. Thus in terms of the said decision this Court will not interfere with the exercise of the discretion of the court of first instance, which is the order of learned Single Judge, and substitute its own discretion except where the discretion is shown to have been exercised arbitrarily or capricious or perversely or where a court has ignored the settled principles of law regulating grant or refusal of interlocutory injunctions. This Court has also not to reassess the material and seek to reach a conclusion different from the one reached by the court below if the one reached by the court was reasonably possible on the material placed before it. The mere fact that this Court may have reached to a contrary conclusion at the trial stage would not be thus good ground to interfere with the order of the learned Single Judge if the discretion has been exercised by the learned Single Judge reasonably and in a judicial manner. The fact that the appellate court would have taken a different view has been held by the Supreme Court not to justify interference with the trial courts exercise of jurisdiction.
25. After assessing the pros and cons of these cases the following factors emerge. The patent in question is new one. It was registered in the year 2004. The appellants filed the suit in the year 2006, i.e. after the lapse of two years only. By no stretch of imagination it can be said to be sufficiently old. There are no conflictions on the point that the patent is less than six years old. Secondly, there are tangible grounds for suspicion of the alleged invention. There lies no rub in granting damages which would provide an adequate remedy should the claim succeed. Above all it will not be proper to upset the well reasoned judgment of the trial court at this stage. The trial court has meticulously checked the record with precision and clarity. All the three essential conditions viz, prima facie case, balance of convenience and irreparable loss lean on the side of the respondents.
26. Appeal being merit-less is dismissed. The copy of this judgment be sent to trial court forthwith.
CM Nos. 2534-35/2007 in FAO 70/2007
CM Nos. 2538-39/2007 in FAO 71/2007
In view of the dismissal of the appeal, no further orders are required to be passed in these applications and the same are dismissed.
prabhakar singh
(Expert) 13 October 2011
F. Hoffmann-La Roche Ltd. & Anr. vs Cipla Ltd. on 24 April, 2009
Author: Dr. S. Muralidhar
IN THE HIGH COURT OF DELHI AT NEW DELHI
FAO (OS) 188/2008
Date of decision: April 24th 2009
F.HOFFMANN-LA ROCHE LTD. & ANR ..... Appellants Through Dr. A.M. Singhvi, Senior Advocate,
Mr. Parag. P. Tripathi, Senior Advocate with
Mr. Raman Kapur, Mr. Manish Kumar, Mr.
Jayant Mehta, Mr. Aditya Kant, Mr. Amit
Kumar, Mr. Amey Nargolkar, & Ms. Arti
Gupta, Advocates for appellant No. 1.
Mr. A.S. Chandhiok, Senior Advocate, Mr.
Jayant Nath, Senior Advocate with Mr. Raman
Kapur, Mr. Manish Kumar, Mr. Jayant Mehta,
Mr. Aditya Kant & Mr. Amit Kumar,
Advocates for appellant No. 2.
versus
CIPLA LTD. ..... Respondent Through Mr. Arun Jaitley, Senior Advocate
with Mr. S. Majumdar, Ms. Prathiba M. Singh,
Ms. Bitika Sharma, Mr. Saurabh Mishra & Ms.
Saya Chowdhary, Advocates.
CORAM:
HON'BLE THE CHIEF JUSTICE
HON'BLE DR. JUSTICE S.MURALIDHAR
1. Whether Reporters of local papers may be
allowed to see the judgment? Yes
2. To be referred to the Reporter or not? Yes
3. Whether the judgment should be reported Yes in Digest?
JUDGMENT
24.04.2009
Dr. S. Muralidhar, J.
1. This appeal by the Plaintiffs F. Hoffmann-La Roche Ltd. (`Roche‟) and OSI Pharmaceuticals Inc. (`OSI‟) is directed against the judgment dated 19th March, 2008 passed by the learned Single Judge of this Court dismissing I.A. No. 642/2008 filed by them in their suit CS (OS) No.89/2008, thereby FAO (O.S.) No. 188/2008 Page 1 of 57 declining their prayer for grant of an interim injunction to restrain the Defendant/Respondent Cipla Limited from manufacturing, offering for sale, selling and exporting the drug Erlotinib, for which the plaintiff No. 2 claimed to hold a patent jointly with Pfizer Products Inc. The impugned judgment nevertheless put the defendant to terms including furnishing an undertaking to pay damages to the plaintiffs in the event of the suit being decreed, to maintain accounts of the sale of its product Erlocip, file in the court quarterly accounts along with the affidavit of one of its directors, and to file in the court annual statement of the sales of Erlocip duly authenticated by its chartered accountants on the basis of its records, including the sales tax and excise returns.
2. For convenience, the appellants are referred to as the plaintiffs and the respondent as the defendant.
Case of the Plaintiffs
3. In the plaint in the suit CS (OS) No.89 of 2008 it is stated that plaintiff No.2 OSI jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule medically termed as a "Human Epidermal Growth Factor Type- 1/Epidermal Growth Factor Receptor" (HER/EGFR) inhibitor, popularly known as Erlotinib. It is claimed that the said drug marked a major breakthrough and innovation in the treatment of cancer. According to the plaintiffs the various tests conducted on Erlotinib have shown a marked increase in the survival benefit in the patients suffering from advanced or metastatic non small cell lung cancer (NSCLC). The metastatic NSCLC is FAO (O.S.) No. 188/2008 Page 2 of 57 most prevalent form of this cancer.
4. The plaintiffs state that Erlotinib is administered in the form of a Tablet and sold under the trademark and name of „Tarceva‟, which is registered in the name of plaintiff No.1 Roche. It is claimed that Erlotinib and its formulation „Tarceva‟ have been approved by the United States (U.S.) Food & Drug Administration (FDA) in the year 2004 and thereafter by the European Union (EU) in the year 2005. On 13th March, 1996 OSI along with Pfizer Products Inc. made an application to the Controller General of Patents, Trademarks and Designs, New Delhi for grant of a patent in respect of Erlotinib. The Controller General of Patents, New Delhi granted the said applicants a certificate bearing Patent No.196774 dated 23rd February, 2007 which was subsequently recorded in the Register of Patents on 6th July, 2007. It is submitted that in terms of the amendments to the Patents Act, 1970 („Act‟) in 2005, the product Erlotinib as well as the process of its manufacture stand patented and are entitled to protection as such. The plaintiffs‟ product Erlotinib Hydrochloride Tablets (Tarceva) was registered by the Central Drug Standard Control Organisation, Directorate General of Health Services, Government of India under Registration Certificate dated 23rd December 2005 in the name of plaintiff No.1 Roche.
5. On 8th January, 2001, plaintiff No.2 OSI and plaintiff No.1 Roche entered into a development collaboration and licensing agreement whereby Roche was granted licence to use and sell and offer for sale the licenced products of the former including Erlotinib. Roche was further licenced and authorized to cause enforcement of any infringement of property rights of any of the products of FAO (O.S.) No. 188/2008 Page 3 of 57 plaintiff No.2 OSI. It is claimed that Roche introduced Tarceva in India some time in April 2006. The announcement regarding the launch of Tarceva by the subsidiary of the Roche Group in India was given wide publicity by the media inter alia in view of its importance in cancer treatment.
6. The defendant Cipla Limited (`Cipla‟), a company incorporated under the Companies Act 1956 and having its registered office at Mumbai, is alleged to have announced in the print and electronic media its plan to launch a generic version of Tarceva (Erlotinib) in India. One such news item appeared on 11th January, 2008 in an English daily „Mint‟ having wide circulation in New Delhi, Mumbai and Bangalore. The plaintiffs state that from such news report they learnt for the first time of Cipla‟s plans to infringe and violate the plaintiffs‟ rights. According to the plaintiffs the drug Tarceva (Erlotinib) has been developed after a long sustained research and after incurring enormous expenditure inter alia on the tests which are mandatorily conducted for its efficacy and safety. It was alleged that the said innovation was duly protected under law and that no person except those legally authorized to exercise legal rights associated with the aforementioned patented drug could be allowed or permitted to simulate, re-create it in any manner or in any other name. It was alleged that the defendant had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva (Erlotinib) and that such action of the defendant, as announced by it, would be in blatant violation of the legal rights of the plaintiffs.
7. In para 20 of the plaint it was asserted that the plaintiffs were under imminent threat of violation of their patent rights inter alia at New Delhi. It FAO (O.S.) No. 188/2008 Page 4 of 57 was further asserted that "the application for the patent of the drug and process of manufacture of Tarceva (Erlotinib) was made and the patent was granted at New Delhi". It was argued that, therefore, this Court has territorial jurisdiction to adjudicate the suit. The suit was valued at Rs. 20 lakhs and for the relief of damages, it was tentatively valued at Rs.1 crore.
8. The suit was filed on 15th January, 2008. Along with the suit the plaintiffs filed an application under Order XXXIX Rule 1 Code of Civil Procedure 1908 (CPC), I.A. No. 642/2008, seeking ad-interim injunction restraining the defendant from infringing the plaintiffs patent in respect of Tarceva (Erlotinib).The two important points to be noted at this stage are that the plaintiffs asserted in the plaint that plaintiff No.2 was granted a patent for Tarceva (Erlotinib) jointly with Pfizer Products Inc. It was stated that the certificate bearing patent No. 196774 dated 23rd February, 2007 recorded in the Register of Patents on 6th July, 2007 pertained to Erlotinib Hydrochloride which was marketed as Tarceva. Secondly, in the plaint no details of the specification of the aforementioned patent or the x-ray diffraction of the product (tablet) Tarceva or the defendant‟s Erlocip was indicated. Plea of the defendant in its written statement to the injunction application
9. The suit was listed before the learned Single Judge on 15th January, 2008, on which date the defendant appeared. The case was thereafter listed on 18 th January, 2008 for the hearing of the application I.A. No. 642/2008 filed by the plaintiffs seeking ad-interim injunction. The defendant filed an application on 18th January, 2008 for a direction to the plaintiffs to disclose the patent specification. At the hearing on 18th January, 2008, the counsel for the FAO (O.S.) No. 188/2008 Page 5 of 57 plaintiffs handed over to the counsel for the defendant the patent specification.
10. On 21st January, 2008, the defendant filed its written statement to the injunction application along with documents. It was stated that the complete specification which ought to have been disclosed in the plaint was supplied by the plaintiffs only at the hearing of the injunction application. The defendant claimed that it had applied for drug approval for the Erlotinib tablet in May 2007 and the approval was granted in October, 2007. As on December, 2007 it had received approval from the Government of Goa for manufacturing the said tablet in various pack sizes of 30,60,100,500 and 1000 tablets. The defendant had launched the product under the mark Erlocip and the said tablet was used for treatment of lung cancer.
11. It was pointed in the written statement that in terms of the second proviso to Section 11-A(7) of the Patents Act 1970, introduced by the Patents (Amendment) Act, 2005 (effective from 1st January, 2005), in case of patent applications filed under Section 5 (2) [which concerns a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug] the rights of a patentee accrue only from the date of the grant of the patent. It was also pointed out that although a certificate was issued to the plaintiffs by the Controller General of Patents bearing Patent No.196774 dated 23rd February 2007, the pre-grant opposition was disposed of only on 4th July 2007. Therefore the patent could not have been granted with effect from 23rd February 2007. It was submitted that the patent certificate was accordingly incorrect and the proceedings in the suit ought to be stayed till the correct authenticated certificate was produced. It was claimed that the patent FAO (O.S.) No. 188/2008 Page 6 of 57 could not be presumed to be valid unless it was more than six years old and since the patent was a new one patent and "granted under peculiar and suspicious circumstances" no injunction ought to be granted.
12. It was mentioned in para 15 that the defendant had also filed a counter claim along with written statement praying for the revocation of the patent granted to the plaintiff. The grounds for revocation raised in the counter-claim were asked to be treated as part of the written statement.
13. In para 16 of the written statement it was specifically averred that the plaintiffs‟ patent "for which the complete specification is yet to be disclosed for the drug Erlotinib" was "completely invalid". A reference was made to Section 3(d) of the Act and it was submitted that Erlotinib is a derivative of a known patent "Quinazoline". It was stated that there were at least three EU patents dating back to 1993 which disclosed the Quinazoline derivative. One of the said patents disclosed the exact chemical structure as found in the plaintiff‟s patent except for one substitution which is "obvious to any person skilled in the art". Further, the plaintiff had failed to prove that there was "any improved efficacy of the said drug". No figures or data had been provided in support of such claim. It was claimed that there was no invention or inventive step in the patent. The patent compound would be obvious to a person skilled in the art to arrive at. It was specifically averred that "the alleged patented product is nothing but a derivative from Gefitinib of Astrazeneca for which a patent was refused in India".
FAO (O.S.) No. 188/2008 Page 7 of 57
14. It was averred in the written statement that one of the pre-conditions for recently granted patent claim to be protected was that it ought to be "worked fully and commercially". It was pointed that the plaintiff got approval for importing and selling Erlotinib only in December 2005 and even as on date the product was neither easily available nor affordable due to its high pricing. No sales figures for the product for India had been given in the plaint in the attached documents and not even one invoice had been filed by the plaintiff. The plaintiff never chose to obtain exclusive marketing rights (EMRs) during the time that the law in India permitted it.
15. The written statement specifically pleaded public interest. It was pointed out that each tablet of the plaintiffs‟ drug Tarceva costs Rs.4,800/- whereas each tablet the defendant‟s Erlocip costs Rs.1,600/-. Thus, a one month dosage of Tarceva for a patient undergoing treatment for cancer would cost Rs.1.4 lakh whereas the equivalent dosage of Erlocip would cost Rs.46,000/-. It was pointed out that in the context of life saving drugs, it was in the public interest that the drug should be made available at cheap and affordable prices.
16. Along with the written statement, the defendant filed copies of the European Patent "Publication No.0566 226 A1" (hereinafter EP‟226) which was an application of Astrazeneca Limited in the EU for grant of patent in respect of „Gefitinib‟. Among the other documents filed by the defendant was the decision dated 30th August, 2007 of the Controller of Patents in India rejecting the application by Astrazeneca UK Limited for grant of patent in respect of Gefitinib. In the said application Astrazeneca UK Limited had cited EP‟226 as the prior art and claimed that Gefitinib involved an inventive step FAO (O.S.) No. 188/2008 Page 8 of 57 with respect to that prior art and with enhanced efficacy. The Patents Controller concluded that Gefitinib was "obvious and does not involve an inventive step over the prior art EP „226. It was therefore held to be not an invention within the meaning of section 2(1)(j) of the Patents Act, 1970 and no patentable invention within the meaning of section 3(d) of the Patents Act, 1970. In its written statement to the injunction application the defendant also placed on record the documents pertaining to US Patent No.6900221 (hereafter U.S.‟221) filed by OSI in the US for Polymorph-B. The said application was filed on 9th November, 2000 and was granted on 31st May, 2005. Defendant's counter-claim
17. In the counter-claim filed by the defendant it was contended that under Section 2 (1) (ta) of the Patents Act 1970, inserted by the 2005 amendment, the expression „pharmaceutical substance‟ has been defined to mean "any new entity involving one or more inventive steps" and under Section 2 (1) (l) a "new invention" was defined as an invention "which has not been anticipated by publication in any document used in the country or elsewhere in the world before the date of filing a patent application with complete specification." It was contended that the suit patent therefore needed a special scrutiny as to the question of validity in the light of the above provisions which were specific to inventions in the field of pharmaceuticals.
18. In para 3.6 of the counterclaim it was contended by the defendant that the plaintiff "had failed to provide any evidence that the compound of claim 1 of the impugned patent possesses significantly enhanced activity over the closest FAO (O.S.) No. 188/2008 Page 9 of 57 compound of the prior art." In para 3.7 it was averred that the plaintiffs had not provided the relevant data that was required to demonstrate that the claimed compound had a higher therapeutic efficacy. In para 3.8 a reference was made to U.S.‟221 which clearly stated that the compound Erlotinib Hydrochoride was a mixture of two polymorphs A&B and that one needed to separate and purify the B polymorph so as to get to the claimed compound for acceptable efficacy. It was stated that subsequent patent clearly defeated the inventive step of the alleged invention.
19. In para 4 of the counter claim it was averred that the suit patent, i.e., Patent No.196774 [corresponding to US Patent No.5747498 - hereafter U.S.‟498] had been obtained by the plaintiffs by suppression of material information. It was stated in para 4.2 as under:
"It is stated that the patentee knew very well that if it discloses the truth that the claimed product is in the
form of a polymorph then the patent application would
have been rejected at the outset because there is nothing to show that the product has enhanced therapeutic
effect. Therefore by suppression of material facts the
patentee has managed to obtain the impugned patent by
by-passing the provisions of Section 3(d)."
20. In para 5.2 of the counter claim the defendant pointed out as under: "The present impugned patent fails to disclose that the
compound of claim 1 of the impugned patent is actually
a mixture of polymorphs, which is useless for
pharmaceutical use. The patentee has intently and
capriciously withheld material information that is
important for practicing the alleged invention disclosed FAO (O.S.) No. 188/2008 Page 10 of 57 in the impugned patent. Therefore, the defendant states
that the specification of the impugned patent does not
sufficiently describe the invention, particularly with
regard to compound of claim 1 of the impugned patent.
The impugned patent is therefore liable to be rejected on this ground alone."
Defendant's application under O VII R 11 CPC seeking dismissal of the Suit
21. On 30th January, 2008 the defendant filed an application I.A. No.1272/2008 before the learned Single Judge seeking dismissal of the suit. The thrust of this application was that the defendant had discovered that the plaintiffs had made two further applications for grant of patent in respect of the same chemical compound for a different crystal form which was termed by the plaintiffs as B- polymorph. The first application was filed on 14th May, 2002 and published first on May 20, 2005 and thereafter re-published on 23rd February, 2007. In the said application priority was claimed over three US applications one of which was U.S.‟221. The second application which was filed on May 13, 2002 and published on 20th May, 2005 claimed priority over three US applications one of which was U.S.‟221. It was pointed that the suit patent had claimed priority over U.S.‟498 published on 5th May, 1998. A reference was made to the statements made by the plaintiffs in U.S.‟221 which showed that the Indian patent No.196774 was in relation to the hydrochloride compound in the form of mixture of polymorphs A and B which was known to the plaintiffs way back in the year 2000 since this corresponded to U.S.‟498 which was granted in 1998 itself. However, this fact was never stated in the application made before the Patent Controller. Since the admitted position of the plaintiffs was that patent No.196774 was not a preferred form for manufacture of tablets, the FAO (O.S.) No. 188/2008 Page 11 of 57 defendant was curious to know how the plaintiffs were still importing and selling tablets of the said Hydrochloride compound under the brand "Tarceva". It sought to determine the actual crystalline structure of the tablets and accordingly purchased some manufactured in August 2006 from the local market. The x-ray diffraction data of Tarceva sold in India showed that it was "B-Polymorph of the Hydrochloride". This was confirmed by the defendant‟s expert Mr. Manish G. Gangrade who performed the technical evaluation. On an analysis of the X-ray diffraction pattern he came to the follwoing conclusion: "Tarceva tablets are wholly B polymorph of the hydrocholoride salt of N-(3-ethynylphenyl)-6, 7 bis(2-methoxyethoxy)-4-quinazolinamine. I further say that the X-ray powder diffraction of Tarceva clearly goes to show that it is not A polymorph or a mixture of A and B polymorph but is wholly B polymorph of the said compound."
22. It was stated in paras 12, 14 and 15 of the application as under: "12. The plaintiff in its various pleadings has claimed
that the patented drug has been sold by it in India since April, 2006, meaning thereby the drug which is sold in
India is the drug for which the patent has already been
granted, i.e., Patent No.196774. However, an analysis
of the drug which is sold in India and the patent which
is registered as also the patent which is pending in
India reveals that the case of the plaintiff is completely false. The drug sold by the plaintiff in India
appears to relate to the said pending patent
applications and not the granted patent No.196774.
......
14. It is, thus, obvious that the plaintiff has come to this Hon‟ble Court with a completely false and
FAO (O.S.) No. 188/2008 Page 12 of 57 incorrect case. The plaintiff has deliberately failed to file the patent specification in the first place by
claiming confidentiality. When the defendant showed
that as per the statute a patent specification is a public document the plaintiff was forced to reveal the same.
Now it has come to light that the drug which is
marketed by the plaintiff is not at all the product for
which the alleged patent has been obtained. The patent application for the drug which is marketed by
the plaintiff is still pending in the patent office. The plaintiff has also suppressed the fact that it has made
two further Patent Applications for the same
compound, i.e. hydrochloride salt of N(3 ethynylphenyl)-6, 7-bis (2-methoxyethoxy)-4
quinazolinamine in B-Polymorph form. The defendant has already filed pre-grant oppositions
against the said patent applications. Copy of the said
pre-grant oppositions for patent application No.
IN/PCT/2002/00507 and Patent application No.IN/PCL2002/00497 are annexed as Annexure E-6
and Annexure E-7. For ready reference the defendant
is annexing herewith copies of the US Patent Nos.
5747498 and 6900221 downloaded from the USPTO.
The said patent no. 5747498 corresponds to Indian
Patent No.196774 which is the alleged equivalent of
the patent which is subject matter of the present suit,
while US Patent No.6900221 corresponds to the two
aforesaid applications against which the opposition is
filed by the defendant. The patent specification of
Patent application No.IN/PCT/2002/00507 is annexed
as annexure E-8 and the patent specification of Patent
application No. IN/PCT/2002/00497 is annexed as
Annexure E-9.
15. It is, thus, submitted that the entire case of the
plaintiff is based on a false premise. The plaintiff is
FAO (O.S.) No. 188/2008 Page 13 of 57 obviously not marketing the drug which is
allegedly covered by the patent which is already
granted. The drug which is being marketed is a
drug which is related to the subsequent patent
applications in India which are pending. These
facts ought to have been disclosed by the plaintiff
before this Hon'ble Court. The plaintiff has
deliberately claimed in its pleadings that the sales of
the patented drug are approx Rs.13.91 crores when it
was well aware that the drug which is being
manufactured and marketed by it is still pending for
patent protection. Therefore, there has been no sale of
the product form patented under No.196774."
(emphasis supplied)
23. However, while notice was directed to issue in the application on 31st January 2008, on that very date the arguments in the injunction application I.A. No.642/2008 were concluded before the learned Single Judge and orders reserved. Thus in the impugned judgment the learned Single Judge did not advert to I.A. No.1272/2008 although a reference was made in the passing to the facts concerning polymorph-B.
Summary of conclusions of the learned Single Judge
24. The summary of the conclusions arrived at by the learned Single Judge in the impugned judgment dated 19th March, 2008 are as under: (i) Section 3(d) of the Patents Act, 1970 was not merely clarificatory of the pre-existing law as contended by the plaintiffs. The Parliament consciously enacted a standard of known obviousness as a pre-condition of patentability; it also excluded the derivatives of known substances unless they differed significantly in properties with regard to efficacy.
FAO (O.S.) No. 188/2008 Page 14 of 57 (ii) In patent infringement actions the court should not presume that a patent is valid especially if the defendant challenges it; the test to be applied in such event is to find out if the challenge by the defendant is genuine as opposed to a vexatious one and further that the defendant has "an arguable case".
(iii) In the instant case although the plaintiffs‟ case was arguable and disclosed prima facie merit, it had to answer the "credible challenge" raised by the defendant to the validity of the patent. (iv) The order dated 4th July 2007 of the Controller of Patents appeared to have readily accepted the contention of the plaintiffs that the inventive step claimed was not obvious to the unimaginative person skilled in the art and that the substitution of methyl for ethynyl in the third position was not contained in the documents submitted by the defendant. The Controller of Patents failed to appreciate that this was the plaintiffs‟ response to the anticipation argument and was different from the defendant‟s objection on the ground of obviousness.
(v) There was merit in the plea of the defendant that comparative data regarding efficacy of the plaintiffs‟ drug, with existing drugs, was not independently shown at the time of examination of the claim by the Controller of Patents to establish that the product differed significantly in regard to its efficacy from the known substance or derivative.
(vi) The court cannot be unmindful of the general access to life saving products and the possibility that such access would be denied if injunction was granted. If the Court was of the opinion that the public interest in granting an injunction in favour of the plaintiff during the pendency of an infringement action is outweighed by the public interest of ensuring easy and affordable access to a life saving drug, the balance should tilt in favour of the latter. In the instant case irreparable injury would be caused to the public if the injunction was granted as they would be deprived of the
defendant‟s product. Several unknown persons who are not parties to the suit and who would be deprived of the life saving drug FAO (O.S.) No. 188/2008 Page 15 of 57 would not be able to be restituted in monetary terms for the damage that would be caused to them if the injunction were granted.
(vii) The injunction was accordingly refused subject to conditions already adverted to in the earlier paragraphs.
25. This court while admitting the appeal by an order dated 22nd April 2008 did not stay the operation of the impugned judgment. However, it restrained the defendant from exporting Erlocip to countries where the appellants have a registered patent during the pendency of the appeal.
26. At the request of the parties, the appeal was taken up for expeditious final hearing. Mr. Parag Tripathi and Dr. A.M. Singhvi, learned Senior Advocates appeared for the plaintiffs and Mr. Arun Jaitley, learned Senior Advocate and Ms. Pratibha Singh, learned Advocate appeared for the defendant. Plaintiffs' subsequent application for grant of patent in respect of Polymorph B
27. In this appeal, one of the significant issues posed by the defendant, which has a bearing on whether the plaintiffs have made out a prima facie case for grant of injunction, is that the specification for the suit patent (i.e. patent No.196774 corresponding to U.S.‟498) showed that it was in respect of Erlotinib Hydrchloride Polymorphs A+B which was on their own showing an unstable form which could not be administered as such. It was contended that the case of the plaintiffs themselves was that it was Polymorph B which was the more stable form of the compound which could be administered in the tablet form. The x-ray diffraction pattern of the tablet Tarceva showed that it FAO (O.S.) No. 188/2008 Page 16 of 57 corresponded to Polymorph B for which the plaintiffs did not yet hold a patent. Their application for the grant of patent for Polymorph B was pending consideration. It was submitted that therefore not even a prima facie case was made out by the plaintiffs since they were seeking an injunction against the defendant in respect of a drug for which they did not yet hold a patent. Moreover, this fact had been suppressed by the plaintiffs both before the Controller of Patents as well as in the suit. On this sole ground injunction ought to have been refused.
28. It was pointed out by learned Senior Counsel for the defendant that the plaintiffs had been changing their stand in regard to polymorph B in the pending application before the Controller of Patents and during the hearing of the present appeal. Clearly the plaintiff s were trying to mislead both this court as well as Controller of Patents to the effect that Polymorph B was subsumed in Polymorphs A and B. In fact it was initially contended before the Patents Controller that the closest prior art i.e. U.S.‟498 did not teach a compound of Polymorph B free of Polymorph A whereas in the subsequent letter dated 18th August 2008 the plaintiffs sought to contend that the earlier compound (polymorphs A and B) included all known and unknown polymorphs. If in fact Tarceva corresponded to polymorphs A and B, there was no need for the plaintiffs to have applied for a separate patent in respect of polymorph B. In any event polymorph B also could not be granted a patent since it was not patentable under Section 3 (d) and further the plaintiffs failed to demonstrate any enhanced efficacy over the known closest prior art polymorphs A and B. It is pointed out that in the published literature pertaining to the history of Roche, which was placed on record by the plaintiffs themselves, it was claimed that FAO (O.S.) No. 188/2008 Page 17 of 57 Tarceva was invented only in 2004. Clearly therefore Polymorph B form of Erlotinib Hydrochloride (which was the tablet form of Erlotinib Hydrochloride and marketed as Tarceva) was not known to the plaintiffs at the time they applied for a patent for Erlotinib Hydrochloride as a combination of Polymorphs A and B. Therefore Polymorph B could not be said to be subsumed in the compound of a combination of Polymorphs A and B.
29. The response of the plaintiffs to this contention was that the fact that they had applied for a separate patent in respect of Polymorph B would make no difference to the claim based on the granted patent in respect of Polymorphs A and B. This was because Polymorph B was subsumed in the compound which was a mixture of polymorphs A and B. As regards non-mention of the above facts before the learned Single Judge it is submitted that the application for Polymorph B was independent of the patent validly granted to the plaintiffs in respect of Polymorphs A and B. Inasmuch as even the defendant had in the written statement proceeded on the footing that the plaintiffs held a patent for Tarceva, and had therefore raised a challenge to the validity of the said patent, the Learned Single Judge was justified in not adverting to the contentions raised in the counter-claim and the I.A.1272 of 2008 while deciding the injunction application. It is further submitted that since the counter-claim and the I.A.1272 of 2008 were pending consideration before the learned Single Judge, this Court should not in deciding this appeal advert to the contentions raised therein.
30. Since this is an issue that did not arise for consideration before the learned Single Judge, and has been specifically raised in the appeal, this Court FAO (O.S.) No. 188/2008 Page 18 of 57 proposes to deal with it first. It must be noted at the outset that by the time the learned single Judge took up for consideration I.A. No. 642/2008 filed by the plaintiff seeking the ad interim injunction, the defendant had already filed I.A. No. 1272 of 2008 under Order 7 Rule 11 CPC. It had also filed a counter claim. In both these documents the defendant raised the plea that the suit patent pertained to Polymorph A + B whereas Tarceva was Polymorph B. The detailed sequence of the proceedings before the learned Single Judge have already been adverted to earlier in this judgment. The contents of the counter- claim and the IA 1272 of 2008 have also been set out in some detail and therefore need not be repeated. The fact remains that while the above fact concerning Polymorph B was noticed by the learned single Judge in the passing in para 43 of the impugned judgment, the learned Single Judge had no occasion to consider whether this was a relevant factor for determining if the plaintiffs had made out a prima facie case for grant of injunction in their favour.
31. This Court does not find merit in the contention of the plaintiffs that since the counter-claim and I.A. 1272 of 2008 are pending before the learned Single Judge, and in any event the contents thereof have not been discussed in the impugned judgment of the learned Single Judge, this Court should not make any observation in that regard which might prejudice the case of the plaintiffs. The position is that the entire record of the case before the learned single Judge before this Court. It contains both the counter claim as well as I.A. No. 1272 of 2008. While this Court is not deciding either the counter-claim or the I.A. 1272 of 2008, it is not possible to accept the plea of the plaintiffs that the contents thereof are not relevant for deciding whether the plaintiffs had made FAO (O.S.) No. 188/2008 Page 19 of 57 out a prima facie case before the learned single Judge for grant of injunction in their favour.
32. To recapitulate the contention of the defendant is that the plaintiffs suppressed the fact of their having filed a separate application for Polymorph B both before the Controller of Patents as well as the learned Single Judge. The effect of the pendency of the latter application of the plaintiffs for Polymorph B on the grant of patent in their favour in respect of Polymorphs A and B has to be examined.
33. The plaintiffs own case before the Controller of Patents in their „clarificatory‟ letter dated 18th August 2008 is that while in the U.S.A "it is perfectly possible and routinely done to patent incremental inventions e.g. Polymorph B of the main compound in addition to the main/dominating/umbrella compound", in India this is possible only subject to the conditions specified in Section 3 (d) of the Patents Act 1970. In other words Section 3 (d) read with its Explanation is, in the context of pharmaceutical products, an anti-evergreening provision. In the subsequent application for Polymorph B, the plaintiffs asserted that "polymorph B is claimed to be thermodynamically more stable and it helps in providing improved oral dosage in solid form." Although the plaintiffs were quick to add that this did not mean that the umbrella compound and all possible polymorphs thereof whether singly or in mixtures "were not useful and could not be used in solid oral dosage form", it does not answer a fundamental question that arises and which is this. Had the Controller of Patents while examining the plaintiffs‟ claim in respect of the compound which was a FAO (O.S.) No. 188/2008 Page 20 of 57 mixture of Polymorphs A and B been informed or was cognizant of the fact that there was another application pending in respect of Polymorph B in which the above statement was made by the plaintiffs, would he have not had to account for it while deciding the question whether the compound, as a combination of Polymorphs A and B, was demonstrated as showing enhanced efficacy over the closest prior art? From the plaintiffs‟ own showing it would not have been possible for the Controller of Patents to have granted a patent in their favour both in respect of Polymorphs A and B as well as Polymorph B. If the compound which was a combination of Polymorphs A and B was an inventive step over its closest prior art (EP‟226) then clearly Polymorph B was only a different crystal form thereof and would fail the tests of novelty and obviousness. However the patentability tests do not stop there. Section 3 (d) requires the demonstration of enhanced efficacy of the product. Although it was urged by the plaintiffs that stability of a product is not the same thing as its efficacy, it would have to be demonstrated by the Plaintiffs, particularly in light of their statements in the application for grant of a patent in respect of Polymorph B (and their statements in the corresponding patent U.S.‟221) that a compound of Polymorphs A and B (and not A alone or B alone) could be orally administered as a drug. It is hard to imagine that the therapeutic efficacy of a pharmaceutical product could be tested without it even being able to be administered to a sample population.
34. This brings us to another significant issue. Should not an applicant for a patent of a pharmaceutical product be bound to disclose the details of all other applications made by the applicant for grant of patent of derivatives or forms of such product? For instance, in the instant case the application for grant of FAO (O.S.) No. 188/2008 Page 21 of 57 patent for Polymorphs A and B (the suit patent) was considered by the Controller of Patents in February 2007 and a certificate No. 196774 dated 23 rd February 2007 was issued by him. The pre-grant opposition to the suit patent was considered thereafter and rejected by the order dated 6 th July 2007. By this time the plaintiffs had already filed two applications, on 13 th and 14th May 2002, for grant of patent in respect of Polymorph B of the compound of Polymorphs A and B. In these applications a reference was made to both U.S.‟498 and U.S‟221 which were for Polymorphs A and B and Polymorph B alone respectively.
35. At this stage it may be useful to refer to the U.S‟221 which was granted to the plaintiffs for Polymorph B. The title begins with the words "Stable Polymorph on N-(3-Ethnylphenyl)-6, 7-Bis (2 Methoxyethoxy)-4- Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses thereof." In the said document a reference is made to the earlier US Patent No.5747498 issued on May 5, 1998 (which corresponds to Erlotinib Hydrocloride a combination of Polymorphs A&B). A reference was made to the mesylate form of the compound which is easily deliverable according to parenteral methods of administration. By contrast, the hydrochloride compound was stated to be "preferred with respect to solid administration such as with tablets and oral administration". The „Summary‟ of the invention stated that the "present invention relates to polymorphs, and methods for the selective production of polymorphs of N-(3-Ethnylphenyl)-6,7-Bis(2Methoxyethoxy)-4- Quinazolinamine Hydrochloride, particularly in the stable polymorph form". It was further disclosed in the said application as under: "Stability of the hydrochloride compound is of concern for its use in the treatment of patients since variations will affect effective FAO (O.S.) No. 188/2008 Page 22 of 57 dosage level and administration. It has been discovered that the hydrochloride of N-(3-ethynylphenyl)-6.7 bis(2-methoxyethoxy)- 4-quinazoliamine exists in two polymorph states, polymorph A and B. This contrasts with the mesylate compounds which exist in three polymorph states (mesylate polymorphs A, B and C). Polymorph B of the hydrochloride was found to be the
thermodynamically most stable and desirable form and the present invention comprises the polymorph B compound in the
substantially pure polymorphic B form and pharmaceutical compositions of the substantially pure form of polymorph B, particularly in tablet form and a method of the selective production of the compound.
The hydrochloride compound disclosed in the U.S. Pat. No. 5,747,498 actually comprises a mixture of the polymorphs A and B, which, because of its partially reduced stability (i.e. from the polymorph A component), was not more preferred for tablet form than the mesylate salt forms."
36. In the subsequent Polymorph B patent specification the plaintiff admitted that "the Hydrocholoride compound disclosed in the US patent no. 5747498 actually comprised a mixture of Polymorphs A and B, which, because of its partially reduced stability (i.e from the Polymorph A component) was not more preferred for tablet form than the mesylate salt forms." It was further stated that "Polymorph B of the Hydrochloride was found to be the thermodynamically most stable and desirable form and the present invention comprises the Polymorph B compound in the substantially pure Polymorphic B form and pharmaceutical compositions of the substantially pure form of Polymorph B, particularly in tablet form and a method of the selective production of the compound."
FAO (O.S.) No. 188/2008 Page 23 of 57
37. Had the Controller of Patents been cognizant of this fact when he considered the application for the grant of the suit patent, he would have had to address the issue whether it was the combination of Polymorphs A and B or Polymorph B alone which satisfied all the patentability tests vis-a-vis Section 3 (d). He would have asked to examine in some detail what was in fact claimed and stated in U.S.‟498 and U.S.‟221. It may be noted that the application for U.S.‟498 was made on 28th May 1996 and granted on 5th May 1998. The application for U.S.‟221 was made on 9th November 2000 and granted on 31st May 2005. So by the time Patent No. 196774 was granted on 23 rd February 2007 to the plaintiffs, the facts concerning U.S.‟498 and U.S.‟221 were already known to the plaintiffs. The failure by the plaintiffs to bring the above facts to the notice of the Controller of Patents at the time of consideration of their application for patent for the compound of a combination of Polymorphs A and B was not consistent with the requirement of a full disclosure. The plaintiffs cannot be heard to say that after all the applications for grant of patent in respect of Polymorph B were pending before the Controller of Patents and he should have known that fact any way. It is perfectly possible that the Controller of Patents might not know, unless his attention is drawn to the fact, of other pending applications concerning the derivatives and forms of the product in question. It is also possible that the pre-grant opposer is not aware of them. Certainly the applicant would, as in this case, know how many more applications it has filed which are pending consideration. It would know what statements it made in the corresponding patents granted to it elsewhere. This would be relevant not only for the tests of novelty and obviousness but of efficacy as well.
FAO (O.S.) No. 188/2008 Page 24 of 57
38. There is more to the effect of non-disclosure by the plaintiffs to the Controller of Patents of the fact of their pending applications for Polymorph B when their application for the product being a combination of Polymorphs A and B was being considered. This Court notices that the plaintiffs have in their reply to the pre-grant opposition of the defendant to their application for grant of patent in respect of Polymorph B, and later in their letter dated 18 th August 2008 addressed to the Controller of Patents, acknowledged their contradictory stands. The plaintiffs‟ stand initially was that U.S.‟498 (which corresponded to Indian Patent No. 196774) "does not contain an unambiguous disclosure of Polymorph B free of Polymorph A." In para 9.4 of their reply to the opposition of the defendant the plaintiffs stated: "There is no indication in the US‟498 that there are different polymorphs of hydrochloride salt." In para 10.2 of the reply to the opposition it was stated that the Polymorph forms were not deemed to be within the prior art; that the US „498 (suit patent) was silent on the Polymorphs and so was the suit patent which was granted in 2007. It was further contended in para 10.3 that the inventors unexpectedly discovered in an around 1999 that Polymorph B had superior stability properties that made it particularly suited for solid oral dosage forms. It was contended in para 11.3 "the stable Polymorph B had been successfully used in human clinical trials before the examination of the application of the impugned patent and much prior to the filing of the suit." Even in the US the stand of the plaintiff while prosecuting its Polymorph B patent was that although the lung cancer was mentioned in „498 patent, NSCLC was not. The stand of the plaintiff, therefore, appears to be that Polymorph A + B of Erlotinib Hydrochloride covered under the US „498 deals with lung cancer and not with NSCLC. However, in their „clarificatory‟ letter dated 18th August 2008 the plaintiffs did a „flip-flop‟ and FAO (O.S.) No. 188/2008 Page 25 of 57 contended that U.S.‟498 "is for the main compound erlotinib hydrochloride which includes all possible polymorphs of main compound known and unknown." Also, they sought to contend that what they were claiming was a „selection invention‟ limited only to Polymorph B which is substantially free of Polymorph A. While this Court is not called upon to comment on whether this flip flop is permissible or tenable, it is plain that the change in stand would admittedly have a direct impact on the question of patentability of either a compound of Polymorphs A and B or of Polymorph B free of Polymorph A. This made the full disclosure by the plaintiffs of all the facts pertaining not only to the „umbrella‟ compound but the crystal or other forms of the product to the Controller of Patents imperative. It can be said with some certainty that such disclosure would have impacted the decision on the patentability of compound of Polymorphs A and B. When the defendant therefore questioned the validity of Patent No.196774 on the above ground, it did raise a more than credible challenge.
39. The effect of non-disclosure of the above facts by the plaintiffs in their plaint in the suit will be considered next. Admittedly the plaintiffs did not disclose the above facts even while they asserted that Patent No.196774 covered the product being marketed by them as Tarceva. The plaintiffs should have been candid and disclosed to the Court that they had filed separate applications for Polymorph B. They may have taken the plea, as they did repeatedly before this Court, that the subsequent application for Polymorph B was out of abundant caution and that Polymorph B was subsumed in the compound which was a combination of Polymorphs A and B. However, this was not done and this Court has had no valid explanation offered by the FAO (O.S.) No. 188/2008 Page 26 of 57 plaintiffs for this non-disclosure. Also, it may be recalled that the plaintiffs also did not disclose the complete specification of the product till the defendant filed an application seeking the information. There could well be a situation where the plaintiffs were pressing for an ex parte ad interim injunction. The effect of the failure to disclose the complete specification of the product and the facts concerning the pending applications for Polymorph B would be that the learned Single Judge would not have the occasion to consider if in fact the suit patent covered Tarceva. This, in the considered view of this Court, is sufficient ground to hold that the plaintiffs in fact failed to demonstrate before the learned Single Judge and even before this Court that notwithstanding the pending applications in respect of Polymorph B which wholly corresponded to the tablet Tarceva, they had a prima facie case.
40. This Court holds that in an application seeking ad interim injunction in a suit for infringement of patent, it would be incumbent on the plaintiffs to make a full disclosure of the complete specification of the product whose patent is claimed to have been infringed. The plaintiffs will also have to disclose to Court the x-ray diffraction data of the product, particularly if it is a pharmaceutical drug. The plaintiffs have to make an unequivocal disclosure that the patent they hold covers the drug in question; whether there are any other pending applications seeking the grant of patent in respect of any derivatives or forms of the product for which they already hold a patent and the effect of such applications on the suit patent. Short of the above details, the Court being approached for the grant of an ad interim relief will be unable to form a view on whether the plaintiff has made out a prima facie case. Otherwise it would be a case of suppression of material facts that would have a FAO (O.S.) No. 188/2008 Page 27 of 57 bearing on the question.
41. Reverting to the case on hand, what is significant is that when the plaintiffs filed their suit in this Court they was fully aware of the fact that Polymorph B was the more stable form of Erlotinib Hydrochloride. For marketing it in the tablet form, it was Polymorph B, which would be relevant. The plaintiffs knew that a separate application for grant of patent for Polymorph B had been made and obtained in the USA. They knew that in the USA while being granted that patent (which although an exercise in evergreening is stated to be permissible there), it was claimed that the closest prior art U.S.‟498 was for treatment of lung cancer in general not NSCLC in particular. The enhanced efficacy was sought to be thus justified. In short their case was that on its own strength Polymorph B of Erlotinib Hydrochloride deserved an exclusive patent on the ground of inventiveness and enhanced efficacy, non-obviousness and non-teaching by any prior art. Clearly the applications made by the plaintiff before the Controller of Patents for grant of patent in respect of Polymorph B was on the same lines. It is indeed in intriguing why the plaintiffs did not chose to be candid with this Court in making a full disclosure of all the above facts in its plaint. There can be no manner of doubt that had these facts fully disclosed in the plaint and the entire specification of the patent held by the plaintiff together with X-ray diffraction data of Tarceva and Erlocip filed along with the plaint, it is possible that the plaintiff may have had difficulty in showing that the patent held by it (No.196774) covered Tarceva as well. In other words, the Court would have had to first be convinced that the plaintiffs held a patent for the product which was marketed as Tarceva and further that the product of the defendant had a x-ray diffraction data which matched Tarceva as well as the FAO (O.S.) No. 188/2008 Page 28 of 57 compound which was a combination of Polymorphs A and B and not Polymorph B alone.
42. The case of the defendant is founded on the proviso to Section 11 A (7) of the Patents Act 1970 which states: "Provided that the applicant shall not be entitled to institute any proceedings for infringement until the patent has been granted." An off shoot of this argument is that the plaintiffs are admittedly not commercially exploiting the patent granted in their favour for a compound which is a mixture of Polymorphs A and B, since the tablet form corresponds to Polymorph B of the said compound Erlotinib Hydrochloride. In Franz Xaver Huemer v. New Yash Engineers AIR 2000 Del 23 a Division Bench of this Court held that the patent of a product which is not being commercially utilized cannot be enforced. The defendant must be held as having been able to demonstrate prima facie that the plaintiffs are not entitled to enforce Patent No.196774 as such.
43. Therefore, this Court holds that to the extent that the defendant has raised a serious doubt whether the plaintiffs in fact hold a patent for the product sold in the tablet form as Tarceva, the plaintiffs must be held not to have been able to cross the first hurdle of showing that they have a prima facie case in their favour for grant of an order restraining the defendant from marketing Erlocip. The effect of the order dated 15th December 2008 of the Controller of Patents
44. After the orders were reserved in the present appeal, the application filed by the plaintiff for grant of patent in respect of Polymorph B was rejected by the Controller of Patents by an order dated 15th December 2008. The said FAO (O.S.) No. 188/2008 Page 29 of 57 order has been placed on record along with CM No. 219/2009 filed by the plaintiff in the present appeal. A perusal of the said order shows that the rejection was on the ground that the applicant had failed to provide comparative data compared to prior art U.S.‟498 to show any enhancement in the therapeutic efficacy of the polymorph B. Even for the stability and bioavailability they claimed, no data was provided vis-à -vis the prior art U.S.‟498 compound. It was further held: "A mere difference in physical property is a well known conventional variation of the same pure substance not showing an unobvious properties. Therefore, the changes alleged by the applicant is in the physical properties and not in the therapeutic efficacy. I therefore conclude that claim 1 and 2 are not patentable under Section 3 (d) of the Patent (Amendment) Act." Claim 6 of the plaintiffs in relation to composition comprising polymorph B form of Erlotinib was also struck down. The process claims of the plaintiffs in relation to Polymorph B have been set down for hearing.
45. It is sought to be contended by the plaintiffs that since their application for a patent in respect of the product Polymorph B form of Erlotinib stands rejected, the said order "sets at rest the argument of the respondent regarding the Polymorph B application prejudicing and invalidating the present suit or the claim of the appellants for an interlocutory injunction." It was submitted that since the application has been rejected on the ground of non-patentability in terms of Section 3 (d), the Controller of Patents had by implication accepted the argument that Polymorph B was subsumed in Polymorphs A and B. However, in the reply to the application it has been contended by the defendant that this is a misreading of the order dated 15th December 2008 of the FAO (O.S.) No. 188/2008 Page 30 of 57 Controller of Patents. It is pointed that the plaintiff‟s application for Polymorph B was rejected on the ground of failure by them to demonstrate enhanced therapeutic efficacy over the closest prior art, U.S.‟498. The plaintiffs filed a separate application for Polymorph B since they claimed that it was only during further studies and research on Erlotinib Hydrochloride that they found that it was Polymorph B which could be made into a tablet form and not the Erlotinib Hydrchloride prepared according to Example 20 of the suit patent. It is submitted that after the rejection of their application for a patent for Polymorph B, the plaintiffs cannot be expected to be in a better position against the defendant than when the said application was pending.
46. This Court is not aware with the plaintiffs wish to further pursue its application for grant of patent in respect of Polymorph B by challenging the order dated 15th December 2008 passed by the Controller of Patents. This Court therefore refrains from commenting on the said order. Whatever be the outcome in the said proceedings, the fact remains that when the Controller of Patents passed the order dated 6th July 2007 negativing the pre-grant opposition to Patent No.196774, none of the facts pertaining to the separate applications for Polymorph B were accounted for. Those facts did have a bearing on the issue of patentability of the compound which was a combination of Polymorphs A and B. The order dated 15th December 2008 also makes no change to the position as regards the failure of the plaintiffs to make out a prima facie case before the learned Single Judge.
47. The learned Single Judge proceeded on the footing that the plaintiff in fact had a valid patent in its favour for the product Tarceva and proceeded to FAO (O.S.) No. 188/2008 Page 31 of 57 examine whether despite the plaintiffs holding such patent, it can be denied injunction. However, in view of the above decision of this Court the case has attained a different complexion. This Court finds that the plaintiffs ought to have been refused injunction for their failure to make out a prima facie case.
48. This court nevertheless proposes to consider the points raised in the appeal independent of the finding on the issue of maintainability since extensive arguments have been addressed on this aspect.
Principles that should govern while considering an application for grant of an injunction in a suit for infringement of a patent
49. The submission of the appellant is that once the plaintiff has been able to show that it has a prima facie case, injunction should automatically follow. Since the plaintiffs hold a valid patent in respect of Erlotinib Hydrochloride (polymorphs A&B), which was not shown by the defendant to have been obtained by fraud, the plaintiff had made out a prima facie case of infringement and an injunction should automatically follow. It is submitted that that the patent granted to the plaintiffs in the instant case has undergone multiple level scrutiny and examination in terms of the procedures outlined under the Patents Act, 1970 as amended in 2005. The publication of the application under Section 11(A)(7), the request for examination by the application under Section 11(B) (i.e. the examination by any third party interested), overall examination by an expert technically qualified as examiner under Section 12, the consideration of the examiner‟s report by the Controller under Section 14, the disposal of the pre-grant opposition to the plaintiff‟s application for grant of patent by any person in terms of Section 25(1), a full blown post grant opposition under Section 25(2) and the final grant of patent upon an overall FAO (O.S.) No. 188/2008 Page 32 of 57 holistic view under Section 43. It is submitted that the grant of a patent after following the procedure involving multi-layered scrutiny must be given considerable weight. Unless the defendant is able to discharge the heavy burden of showing that it has a stronger prima facie case than the plaintiff, it should not be permitted to defeat the right of the plaintiff to an injunction against infringement by casually raising a challenge to the validity of such patent. Reliance is placed on the judgment in American Cyanamid Company v. Ethicon Ltd. (1975) 1 All. E.R. 504, Raj Prakash v. Mangat Ram Choudhary AIR 1978 Delhi 1, Proctor v. Bayley 1889 (XLII) Ch. 390, Telemecanique Controls v. Schnider 94 (2001) DLT 865, Hindustan Lever v. Lalit Wadhwa 2007 (35) PTC 377, Midas Hygiene Industries (P) Ltd. v. Sudhir Bhatia (2004) 3 SCC 90, Laxmi Patel v. Chetan Bhat Shah JT 2001 (10) SC 285.
50. The judgment of the learned single Judge has been assailed as proceeding on incorrect principles. A separate note has been filed by the plaintiff indicating what according to it are errors in judgment. It sought to be contended that even after finding that there was a prima facie case made out by the plaintiff, the learned single Judge split it into a two-stage test by first determining whether the plaintiff had a prima facie case and thereafter whether there was a prima facie case made out by the defendant. It is submitted that there is no precedent indicated by the learned single Judge for adopting this course. The judgment is criticized for using a multitude of phrases in deciding this issue. At one place the impugned judgment holds that the case of the defendant "is not implausible", at another place it is stated that defendant has "a credible or arguable challenge to the plaintiff‟s patent" and at another place FAO (O.S.) No. 188/2008 Page 33 of 57 that the defendant has not made "a palpably unfounded claim".
51. It is contended on behalf of the defendant that under the Patents Act, 1970, as contrasted with the Trade Marks 1999, there is no presumption of validity of a patent. This is evident from reading of Section 13(4) as well as Sections 64 and 107 of the Act. It is possible to raise multiple challenges to validity of patent at various stages. It could be at the pre-grant and post-grant stages before the Controller of Patents. Thereafter before the Appellate Board or in a suit for infringement the defendant could question the validity of a patent on the grounds set out in Section 64. The patent in the instant case was, therefore, vulnerable to challenge notwithstanding it surviving the challenge at the pre- grant stage. The object behind this was to ensure that known inventions are not granted patents and that the patent is used for the public benefit.
52. The above submissions have been considered. It must be clarified that this Court has held already that the Plaintiffs have failed to make out a prima facie case. The above submissions of the plaintiffs are therefore being dealt with assuming, as the learned Single Judge did, that the Plaintiffs have made out a prima facie case. Given the scheme of Patents Act it appears to this Court that it does contemplate multiple challenges to the validity of a patent. Unlike Section 31 of the Trade Marks Act which raises a prima facie presumption of validity, Section 13(4) of the Patents Act 1970 specifically states that the investigations under Section 12 "shall not be deemed in any way to warrant the validity of any patent." Section 48 of the Act also is in the form of a negative right preventing third parties, not having the consent of the patent holder, from making, selling or importing the said product or using the patented process for FAO (O.S.) No. 188/2008 Page 34 of 57 using or offering for sell the product obtained directly by such process. It is also made subject to the other provisions of the Act. This is very different from the scheme of the Trade Marks Act as contained in Section 28 thereof. Section 3(d) itself raises several barriers to the grant of a patent particularly in the context of pharmaceutical products. It proceeds on the footing inventions are essentially for public benefit and that non-inventions should not pass off as inventions. The purpose of the legal regime in the area is to ensure that the inventions should benefit the public at large. The mere registration of the patent does not guarantee its resistance to subsequent challenges. The challenge can be in the form of a counter claim in a suit on the grounds set out in Section 64. Under Sections 92 and 92 A the Central Government can step at any time by invoking the provision for compulsory licencing by way of notification. Therefore, the fact that there is a mechanism to control the monopoly of a patent holder (Section 84 and Section 92) and to control prices (by means of the drug price control order) will not protect an invalid grant of patent.
53. The plea of the plaintiff that since there is a multi-layered, multi-level examination of the opposition to the grant of patent it should accorded the highest weightage, is not entirely correct. The contention that there is a heavy burden on the defendant to discharge since it has to establish that it has a stronger prima facie case of the plaintiff is contra indicated of the decisions in the context of Section 13(4). Reference may be made to the decisions in Biswanath Prasad Radhey Shyam v. M/s Hindustan Metal Industries AIR 1982 SC 1444, Standipack Pvt. Ltd. v. Oswal Trading Co. Ltd. AIR 2000 Del 23, Bilcare Ltd. v. Amartara Pvt. Ltd. 2007 (34) PTC 419(Del), Surendra Lal FAO (O.S.) No. 188/2008 Page 35 of 57 Mahendra v. Jain Glazers (1979) 11 SCC 511. In BeechamGroup Ltd. v. Bristol Laboratories Pty Ltd. (1967-68) 118 CLR 618 and Australian Broadcasting Corporation v. O'Neill (2006)229 ALR 457 it was held that the defendant alleging invalidity bears the onus of establishing that there is "a serious question" to be tried on that issue. In Hexal Australai Pty Ltd. v. Roche Therapeutics Inc. 66 IPR 325 it was held that where the validity of a patent is raised in interlocutory proceedings, "the onus lies on the party asserting invalidity to show that want of validity is a triable question." In Abbot Laboratories v. Andrx Pharmaceuticals Inc. (decision dated 22 nd June 2006 of the U.S.Court of Appeals for the Federal Circuit 05-1433) the Court of Appeals followed its earlier ruling in Helifix Ltd. v. Blok-Lok Ltd. 208 F.3d 1339 where it was held (at 1359): "In resisting a preliminary injunction, however, one need not make out a case of actual invalidity. Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial. The showing of a substantial question as to invalidity thus requires less proof than the clear and convincing showing necessary to establish invalidity itself." (emphasis supplied) In Erico Int'll Corprn v. Vutec Corprn (U.S.Court of Appeals for the Federal Circuit, 2007-1168) it was held that the "defendant must put forth a substantial question of invalidity to show that the claims at issue are vulnerable."
54. In the present case, the grant of a patent to the plaintiffs for Erlotinib Hydrochloride as a mixture of Polymorphs A and B will not ipso facto entitle them to an interim injunction if the defendant is able to satisfy the court that there is a serious question to be tried as to the validity of the patent. The use by the learned Single Judge of the expressions "strong credible challenge", FAO (O.S.) No. 188/2008 Page 36 of 57 "arguable case" or that the defendants claim being not unfounded, cannot be termed as vague and inconsistent since they convey the same meaning in the context of the strength of the defendant‟s challenge.
55. The question before this Court is when can it be said that the defendant has raised a credible challenge to the validity of a patent held by the plaintiff in an infringement action? During the course of the argument it was suggested by counsel that the challenge had to be both strong and credible. Also, the defendant resisting the grant of injunction by challenging the validity of the patent is at this stage required to show that the patent is "vulnerable" and that the challenge raises a "serious substantial question" and a triable issue. Without indulging in an exercise in semantics, the Court when faced with a prayer for grant of injunction and a corresponding plea of the defendant challenging the validity of the patent itself, must enquire whether the defendant has raised a credible challenge. In other words, that would in the context of pharmaceutical products, invite scrutiny of the order granting patent in the light of Section 3(d) and the grounds set out in Section 64 of the Patents Act 1970. At this stage of course the Court is not expected to examine the challenge in any great detail and arrive at a definite finding on the question of validity. That will have to await the trial. At the present stage of considering the grant of an interim injunction, the defendant has to show that the patent that has been granted is vulnerable to challenge. Consequently, this Court rejects the contentions of the plaintiffs on this issue and affirms the impugned judgment of the learned Single Judge.
Defendant's challenge to the validity of the patent
56. The next question is whether the defendants have in fact been able to FAO (O.S.) No. 188/2008 Page 37 of 57 demonstrate that there exist serious triable issues concerning the validity of Patent No.196774 granted to the plaintiffs.
57. The plaintiffs submit that apart from merely challenging the validity of the patent granted in their favour, the defendant had not produced any material to demonstrate that the compound for which the patent was granted was not a novel invention with proved enhanced efficacy over the closest prior art. Since the plaintiffs had demonstrated successfully before the Controller of Patents that their compound was an inventive step over the closest prior art, the burden lay on the defendant to show that the inventive step was obvious to a person having ordinary skill in the art. Contrary to the claim of the defendant, Erlotinib Hydrocholoride could not be anticipated with reference to the closest prior art EP‟226. Methyl and ethynyl groups are different and the substitution of ethynyl with methyl in the theta position could not have been anticipated even by a person skilled in the art with reference to the EP‟226 patent.
58. On the other hand it is contended by the defendant that Section 3(d) of the Act introduced in 2005 has made dramatic changes to the patent law regime, particularly, in the context of drugs and medicines. Unless the drug or compound is proved to be of enhanced efficacy and is an inventive step, the patent is not granted. Where the compound is a new form of a known substance (evergreening), unless it is shown to demonstrate enhanced efficacy, the mere discovery of a new property or a new use would not entitle the applicant for the grant of a patent. The derivatives of the known substances would also be considered as the same substances unless they differ significantly in properties with regard to the efficacy. FAO (O.S.) No. 188/2008 Page 38 of 57
59. It is further submitted by the defendant that a perusal of the order dated 4th July 2007 of the Controller of Patents shows that the Controller confused the concepts of inventive step, anticipation and obviousness. Even as regards the question of efficacy the plaintiffs failed to produce relevant data. The journals referred to in the order of the Controller pertained to results of the research conducted by or sponsored by OSI itself. Such studies could not, therefore, have inspired credibility as regards the proof of enhanced efficacy of the product over the closest prior art. Irrespective of the above submissions, the defendant submits that the product claimed to be a combination of polymorphs A and B was clearly anticipated by the closest prior art, EP‟226. It was also anticipated in the earlier patents granted by the EU. It is submitted that the claimed invention was neither novel nor an inventive step over the closest prior art.
60. The above submissions have been considered. It is not possible to accept the contention of the plaintiffs that the Section 3(d) does not bring any significant change to the Patents Act. Not only has the substantive portion of Section 3(d) indicated a change in 2005 but the Explanation which has been added appears to particularly target pharmaceutical products. It discourages evergreening and prevents such derivative or other forms of the already patented product being granted patent unless the derivatives or other forms "differ significantly in properties in regard to efficacy." The plaintiffs contest the argument that Erlotinib Hydrochloride is a derivative of a known substance EP‟226. However, it appears that the closest prior art does teach the compound for which patent has been granted to the plaintiffs. Therefore, unless the enhanced efficacy as mandated by Section 3(d) was demonstrated, patent FAO (O.S.) No. 188/2008 Page 39 of 57 could not have been granted. The defendant has been able to show that order of the Controller of Patents was arguably deficient on this aspect. The defendant therefore must be taken to have raised a credible challenge to the validity of the patent.
61. Elaborate arguments have been addressed on whether Erlotinib Hydrochloride was only a modified form of Gefitinib. The order of the Patent Controller refers to EP „226 which was relied upon by the defendant to suggest that the molecule structure of the suit patent was similar to those disclosed in the aforementioned patent. In other words, it was contended by the defendant that the substitution of Methyl with Ethynyl would be obvious to a person skilled in the art when the closest prior art is taken to be Gefitinib which was claimed in EP „226. It is sought to be contended by the plaintiffs on the other hand that Erlotnib Hydrochloride was a derivative of another disclosed compound / structure (Example 51) and not Gefitinib. It is submitted that the defendant should not be permitted by a device of reverse engineering to claim that the substitution of Methyl by Ethynyl was obvious.
62. In Pfizer v. Apotex (U.S.Court of Appeal, 2006-1261), it was held that for the test of obviousness only a reasonable expectation of success and not a guarantee is needed. In Aventis v. Lupin (U.S.Court of Appeal, 2006-1530) it was held that "where the prior art gives the reason or motivation to make the claimed compositions, creates a prima facie case of obviousness."
63. According to the defendant with reference to the patent held by the plaintiff for Erlotinib Hydrochloride as a combination of Polymorphs A and B, the FAO (O.S.) No. 188/2008 Page 40 of 57 closest prior art is a molecule structure disclosed in EP „226 which was the patent granted to Zeneca Limited. The Patent Controller ought to have examined EP „226 when examining the claim of the plaintiff. According to the defendant the closest prior art EP „226 patent disclosed a molecule structure in a Quinazoline derivative with Methyl group at the third position. It is stated that such substitution is obvious to persons skilled in the art and that persons wishing to obtain further compounds having anti-cancer properties would have been easily motivated to substitute methyl with the specifically disclosed ethynyl group. It is stated that methyl and ethynyl are normally used interchangeably in chemical arts because they share common attributes.
64. The plaintiffs on the other hand have elaborately argued on the "teaching, suggestion and the motivation to try" (TSM) test and submitted that the inventive step in the patent granted to it is in providing a compound which shows improved efficacy in its treatment of various cancers. The state of art on the priority date of the patent was Gefitinib. The inventive step in the patent goes beyond the state of art as demonstrated by the published articles in the journals. It was argued that FDA and the Drug Regulator of the concerned European agency directed withdrawal of the alleged prior art Gefitinib. In fact even Astrazeneca agreed to the same. It also did not object, in any region of the world, to the plaintiff being granted patent for Erlotinib Hydrochloride. It is urged that the obvious inference was that Erlotinib Hydrochloride was far better in enhanced efficacy than Gefitinib. It is therefore urged that a person of ordinary skill in the art would find no motivation at all to replace the methyl group at position 3 by an ethynyl group. It is further argued that even if a person of ordinary skill attempted to modify Example 51 of EP „226, the FAO (O.S.) No. 188/2008 Page 41 of 57 motivation would be to modify 6 or 7 positions not the third position. Even if such person was motivated to change the substitution in the third position the choice would be a halogen such a chlorine and fluorine and not ethynyl.
65. In the view of this Court, a bare perusal of the order of the Patent Controller would indicate that neither of the above arguments has been considered, and in any event not in the detailed manner in which they have been advanced before this Court. It is perfectly possible that the Controller had no occasion to consider such argument as it was not raised before him. That is perhaps the very purpose of the legislature permitting a challenge by a defendant to the validity of a patent in answer to an infringement suit, even if such defendant had not earlier raised an opposition either at pre-grant or the post-grant stages. Therefore a patent which survives the pre-grant and post- grant challenges can still be made vulnerable on grounds different from the ones raised at those stages. The fact that the challenge is on grounds not urged at those stages, would lend credibility to the challenge. If the challenge is on the same grounds considered and rejected by the Controller of Patents, then of course, the burden on the defendant to demonstrate credibility of the challenge would be considerably higher degree.
66. There are other factors pointed out by the defendant to render the patent vulnerable to challenge. It is submitted that the Controller of Patents has confused the tests of inventiveness with obviousness. For instance it is observed by the Controller that "sometimes the modification in the prior art technologies which appear to be minor may bring great revolutions in the world which could never be predicted by the society of intellectuals ........" FAO (O.S.) No. 188/2008 Page 42 of 57 This, it is pointed out, is really about „anticipation‟ and not „obviousness‟. It was not enough for the plaintiffs to show that the defendant was unable to „anticipate‟ the product in question by starting from the closest prior art EP‟226. The plaintiffs had still to show that it would not have been obvious to the person having ordinary skill in the art. Reliance is placed on the decisions in Shire Biochem v. Ministry of Health 2008 FC 538 to underscore the difference between novelty and obviousness. The difference between anticipation and obviousness is brought out in the decisions Synthon BV v. Smith Kline Beecham [2005] UK HL 59 and KSR International Company v. Teleflex 550 US 1 (2007).
67. The decision in KSR International makes a conscious departure from the rigidity in the application of the TSM test applied to determine if the invention in question is patentable. It was observed therein (550 US 1 at 15): "The obviousness analysis cannot be confined to a formalistic conception of the words teaching, suggestion and motivation or by overemphasis on the importance of published articles and the explicit content of issued patents...... granting patent protection to advances that would occur in the ordinary course, without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior inventions of their value or utility."
68. The criticism by the defendant of the order of the Controller of Patents is, in the view of this Court, not without merit. The Controller failed to appreciate that the patent was claimed specifically on Example 20 and therefore stood on a footing different from that granted to the plaintiffs in other countries. The FAO (O.S.) No. 188/2008 Page 43 of 57 point about the credibility of the articles published in the journals being the product of researched sponsored by Plaintiff No.2 OSI was not even noticed by the Controller of Patents. The entire discussion on the aspect of enhanced efficacy in the order of the Controller is limited to a mention of these articles. Also, in the order dated 4th July 2007 of the Controller of Patents there is an incomplete sentence when there is a reference to the decided cases. The anomaly of the pre-grant opposition being disposed of only on 4th July 2007 whereas the patent certificate is of 23rd February 2007 remains unexplained. If it was indeed a pre-grant opposition that was being rejected, it is conceivable that the certificate would pre-date it.
69. Elaborate arguments were addressed on the question of balance of convenience on the ground that the judgment of the House of Lords in American Cyanamid requires such factor to be considered once it is shown that the damages would not provide an adequate remedy to the plaintiff in the event of it succeeding at the trial. In the considered view of this Court, this aspect need not be examined in the present case for more than one reason. First, the plaintiffs have, for the reasons discussed earlier, failed to make out a prima facie case in their favour. Even if it is assumed that they have, in view of the fact that the defendant has raised a credible challenge that renders the patent‟s validity vulnerable, the question of balance of convenience does not arise because clearly the Court will not, at the interlocutory stage without the case going to trial, come to the aid of a holder of a patent of doubtful validity seeking to enforce such patent.
70. One submission of Dr. Singhvi that needs to be dealt with at this stage is FAO (O.S.) No. 188/2008 Page 44 of 57 whether the statements made by an applicant for a patent in the applications made by such applicant in other countries would be permitted to be looked into by the Controller of Patents while examining such application. Reference was made to the decision in T.I. Group Automotive System v. V.D. North America 375 F 3d 1126 and the decision dated 2nd August 2006 of the Court of Appeals in Pfizer v. Ranbaxy (06-1179). This Court is unable to accept the above submission. A perusal of the definition of "new invention" in Section 2(1) (l) indicates that the invention or technicality for which a patent is sought should not have been anticipated "by publication in any document or used in the country or elsewhere in the world before the date of filing of a patent application with complete subscriptions, i.e,, the subject matter is not filed in public domain so that it does not form part of the state of the art". The phrase "public domain" and "state of the art" have therefore to admit of a wide scope given the legislative intent in introducing the above definition by the Amendment Act, 2005. It appears that this was introduced in acknowledgement of the fact that a claim by an applicant for a patent anywhere in the world and the statements made therein would be relevant for the authority in India determining whether the invention claimed is indeed a new invention. With the easy availability of information on the internet, it is possible for the patents authorities in this country to ascertain what in fact is the closest prior art and which is a known substance. A statement made by the applicant while prosecuting a patent application in any country would certainly be a relevant material to be considered. The decisions cited by learned counsel are not relevant in this context as the law in this country is governed by the Patents Act 1970 which requires the applicant to make a full disclosure as noticed hereinbefore.
FAO (O.S.) No. 188/2008 Page 45 of 57
71. The discussion on this aspect is concluded by concurring with the learned Single Judge that, assuming that the plaintiffs held a patent for the product which was the subject matter of the suit for infringement, the defendant has raised a credible challenge to the validity of the patent by raising a serious triable and substantial question that renders it vulnerable to challenge. Public Interest
72. That brings us to the last submission of the plaintiffs which is that the learned Single Judge had applied principles not known to law in refusing injunction. The issues of public interest and pricing were not germane or relevant in the context of patent law. Public interest on the other hand required protecting a validly granted patent. The question of availability of the drug at affordable price was provided for in the Patents Act, 1970 by way of provisions for compulsory licencing. Since the legislative intent was to grant a monopoly to the patent holder for at least the first three years after the grant of patent to enable it to recover the enormous costs incurred in research and development of the product, the court should not override such legislative intent on the basis of untested principles. The argument of the plaintiff is that if the rights of a patentee are not respected then it would be contrary to the public interest of encouraging further research. Further it would discourage the requirement of disclosure which inheres in patent regime thereby creating a situation where opportunity of further innovation based on fundamental research on an existing patent product/process would be lost or unduly deferred.
73. An attack was also mounted on the impugned order of the learned single FAO (O.S.) No. 188/2008 Page 46 of 57 Judge for linking up the issue of pricing with public interest. It is submitted since the Act provides for grant of compulsory licence in the event of the patented product not being made available at the reasonable price, it was not for the Court to apply such principles at an anterior interlocutory stage. The legislature has for good reasons granted a statutory monopoly to a patent, although for a limited period. The grant of such limited monopoly must therefore also be taken to be in the public interest. It is submitted that the patentee has the right to exploit the benefits of its research in which it has invested considerable sums. By contrast, a generic drug manufacturer has little or no research and development costs. Therefore as a rule the copier would always price its products lower than the inventor.
74. The plaintiffs contend that the provisions of the Essential Commodities Act, 1953 (ECA) will apply to pharmaceutical drugs as well. It is submitted that the Central Government can also take recourse to the device of a Drug Price Control Order (DPCO) framed under Section 3 ECA to fix the market sale price in respect of bulk drugs both for scheduled as well as non-scheduled formulations. It is accordingly submitted that the judgment of the US Supreme Court in E Bay v. MerExchange [547 US 338(2006)] has to be understood in the context of there being no provision under the American law either for granting any right to the Government to control the prices in the manner indicated, or a power under Section 47 of the Patents Act, 1970 to grant patents subject to conditions including use of the process by the government or even a pre-grant opposition akin to Section 25(1) of the Act. It is submitted that public interest in low cost general drugs has to be balanced by the public interest in protection of patent rights and that the need to encourage scientific FAO (O.S.) No. 188/2008 Page 47 of 57 research in discovering the drug outweighs the public interest in obtaining a low cost generic drug. Reliance is placed on the judgment of the District Court of the US in Eisai Co. v. Teva Pharamaceuticals [dated 28.3.2008/Civ. No.05- 5727 (HAA) (ES)], Payless Shoesource Inc. v. Reebok International Ltd. (998 F.2d 985) and Sanofi - Synthelabo v. Apotex (470 F.3d 1368).
75. The defendant on the other hand counters this submission by submitting that pricing would indeed be a relevant considerations in determining whether the grant of an injunction would adversely affect the easy availability of a life saving drug. Reliance is placed on the decisions in Novartis AG v. Mehar Pharma 2005 (30) PTC 160(Bom.),Franz Xaver Huemer v. New Yash EngineersAIR 1997 Del 79 and Russel Uclaf v. G.D.Searle (1977) Fleet Street Patent Law Reports 125.
76. This court is unable to accept the submissions of the plaintiffs on this aspect. The amendment to the Patent Act 1970 in 2005 introduced Section 83(e) which states that among the general principles applicable to the working of patented inventions regard shall be had "that patents granted do not in any way prohibit Central Government in taking measures to promote public health" and under Section 83 (g) "that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public." Under Section 84 among the grounds on which a person can seek a compulsory licence on a patent is that "the patented invention is not available to the public at reasonably affordable price." The element of public interest is therefore not alien to the scheme of the Patents Act 1970.
FAO (O.S.) No. 188/2008 Page 48 of 57
77. The approach of the learned Single Judge was not inconsistent with the judicial decisions on this aspect. In Franz Xaver Heumer in the context of balance of convenience it was observed (AIR, p. 87):
"33. Balance of convenience has also an important role to play. Stultification of defendants investment, loss of employment, public interest in the product (such a life saving drug), product quality coupled with price, or the defendant being smaller in size, may go against the plaintiff."
78. In Novartis AG the Bombay High Court was considering a case where the defendant challenged the grant in favour of the plaintiff of exclusive marketing rights (EMR) in respect of a drug Imatinib on the ground of lack of novelty. In refusing injunction to the plaintiff it was observed (PTC, pp.173-174) "28. A comparison of what is stated in the application submitted by plaintiffs in Canada for the patent in 1993 and the contents of paragraph 10, in my opinion, definitely raises a serious question as to whether the product in relation to which EMR has been granted is really a new product or not. In paragraph 8 of the plaint, the plaintiffs describe the invention as B crystalline form of Imatinib Mesylate. In paragraph 10, the plaintiffs admit that Imatinib Mesylate crystals were found to be in two forms - Alpha (a) and Beta (B). Alpha was needle shaped. Beta was found to be thermodynamically stable and was prepared for use in
pharmaceutical preparations. Perusal of the application submitted by the plaintiffs in 1993 for patent in Canada shows that the plaintiffs have disclosed the compound as well as its salt. Beta crystals are clearly disclosed in the application. Therefore, in my opinion, apart from other challenges, this challenge can definitely be said to be serious insofar as the validity of EMR granted is concerned and if that be so, in terms of the law that appears to be FAO (O.S.) No. 188/2008 Page 49 of 57 settled referred to above, the EMR being of recent origin, the plaintiffs would not be entitled to the temporary injunction sought. It is further to be seen here that in the present case, it cannot be said that even if the plaintiffs ultimately succeed, the loss or injury that may be caused to the plaintiffs is not incapable of being compensated in terms of money. Indeed, in the plaint, the plaintiffs have worked out loss suffered by them and have in fact sought a monetary decree in relation thereto. In my opinion, the aspect of balance of convenience has also to be answered in favour of the defendants, especially because the drug in relation to which EMR is granted is a anti-cancer drug, is a life saving drug and the plaintiffs do not manufacture the drug in India but import it from foreign country. The
defendants have stated that the demand of capsules is over 30,00,000 per month. This does not appear to have been disputed by the plaintiffs. It is clear that the demand of this drug in India is very large, it is a life saving drug. The defendants manufacture the drug in India. The plaintiffs do not manufacture the drug in India. They state that they will import required quantity of the drug from a foreign country. Therefore, the plaintiffs will rely entirely on the international transport system for making the drug available in India in required quantity. In case interim injunction is granted in favour of the plaintiffs, the manufacturing and marketing network of the defendants so far as the drug is concerned would be dismantled. If due to any problem, the plaintiffs cannot make available the drug in required quantity in India, it obviously will be disastrous for the patients. This
consequence is foreseeable, therefore in my opinion, the Court should not pass any interim order which may possibly lead to such a situation. In my opinion, the aspect of the difference in price of the product of the plaintiffs and the defendants also cannot be ignored, especially at the stage of considering the question whether the plaintiffs are entitled to any interim relief." FAO (O.S.) No. 188/2008 Page 50 of 57
79. In Roussel Uclaf the plaintiffs were a company which held a licence under a patent which gave them exclusive rights to sell in the United Kingdom two drugs, an amide base and a phosphate salt, both giving rise to the same active ingredient in the body. The first defendants began to sell the phosphatic salt in July 1976 and the plaintiffs sought, inter alia, an interlocutory injunction to restrain the sale. The plaintiff‟s sale of the amide base represented 2.2 per cent of their total U.K. sales. They did not market the phosphate salt though they had plans to do so. In certain cases of heart disease the drugs could be life- saving and on other drugs were directly comparable. The High Court while refusing injunction dwelt on the aspect of the drug being a life saving one. It was noticed that there was no other drug available which was comparable with the drug in question and had the same effect. It was held this aspect and the fact that patients suffering from heart disease may easily be suspicious of a new drug and be adversely affected by having to change from one drug to another had to be "taken into account when considering the balance of convenience and whether in all the circumstances the discretion of the court should be exercised to grant an injunction." On the aspect of availability of a life saving drug it was held:
"Finally, therefore, I come to the interesting and, I think novel point as to whether this court ought ever and, in particular, in this case to exercise its discretion to grant an injunction the effect of which will be, temporarily at any rate, to deprive members of the public of the benefit of a `life-saving drug which may be prescribed‟ for otherwise fatal heart diseases. In fairness to Mr. Aldous and the plaintiffs, I should say that it was made clear that if the proper conclusion was that this drug in question was unique they would not feel it right to contend that an injunction should be granted in such a case. It would, of course, be simple, subject to the practical difficulties of distribution, which could probably be FAO (O.S.) No. 188/2008 Page 51 of 57 got over, to make a limited injunction ensuring that patients already on the drug in question continued to be supplied with it. I do not think, however, that such a limitation can deal with the real point, which is whether members of the public, whether they are already patients on the drug or not, should be deprived of the benefit of it. I think this must be a question for decision in the particular circumstances of each case, though I feel that the onus in such cases must be very heavily on the plaintiffs to show that there is little, if any, likelihood of the public being injured by their inability to obtain the drug in question when necessary. A life- saving drug is in an exceptional position. There are often cases where a number of drugs exist alongside each other and are in general all equally efficacious for a particular ailment or disease. If the evidence shows it to be the fact that there may well be cases where it would make little, if any, difference to the public, apart from satisfying personal preference, whether a particular drug was no longer available or not, then in such a case it may well be proper to grant an injunction. At the other end of the scale, however, there is the unique life-saving drug where, in my judgment, it is at least very doubtful if the court in its discretion ever ought to grant an injunction and I cannot at present think of any circumstances where it should. There are infinite variation between these two limits. The present case is very near to the unique end, because the soluble salt has at present no precise equivalent, the base not having, on the evidence, the same biological activity even though the active disopyramide once in the blood will have the same effect, other things being equal, in both cases. To add to this, there is uncontradicted evidence that heart patients are peculiarly sensitive to and fearful of changes in drugs and their regime."
80. Turning to the case on hand, there is no doubt that the product in question is a drug for cancer treatment at the terminal stages. It is the second line treatment after the first line of treatment by way of chemotherapy had proved FAO (O.S.) No. 188/2008 Page 52 of 57 unsuccessful. It is expected to be directed of a particular form of non-small cell lung cancer. This drug is not readily available in India. The plaintiffs do not yet manufacture it in India. They import and sell the drug. Even if the price per tablet is taken to be Rs.3200 as claimed by the plaintiffs it is a drug which is expensive. It is clearly beyond the reach of many patients suffering from this dreaded form of cancer.
81. This Court is inclined to concur with the learned single Judge that in a country like India where question of general public access to life saving drugs assumes great significance, the adverse impact on such access which the grant of injunction in a case like the instant one is likely to have, would have to be accounted for. Erlocip is the Indian equivalent produced by the defendant in India as a generic drug manufacturer. It is priced at Rs.1600 per tablet. Even if this does not make it inexpensive, the question of greater availability of such drug in the market assumes significance.
82. In the considered view of this Court, while it may be possible to distinguish the judgment of the US Supreme Court in E Bay as relating to a case of permanent and not temporary injunction, the traditional four factor test identified in the said judgment does assume relevance even at the stage of grant of an interim injunction. Given the nature of the drug, in the instant case, which admittedly is a life saving one, the fourth test identified in E Bay that the grant of an injunction should not result in the public interest being "disserved" would be relevant.
83. The judgments relied upon by the plaintiffs underscore the approach of FAO (O.S.) No. 188/2008 Page 53 of 57 determining these questions on a case by case basis. Whether indeed the public interest in the availability of the drug to the public at large is outweighed by the need to encourage research in the invention, would obviously differ from case to case and depend on a host of factors. This Court finds no ground to differ with the reasoning or the conclusions arrived at by the learned Single Judge on this aspect after an analysis of all the relevant factors.
84. Even while considering this aspect, the Court is conscious that the defendant has been able to demonstrate prima facie that the plaintiffs do not hold a patent yet for the drug Tarceva, which is the Polymorph B form of the substance for which they hold a patent. Secondly, the defendant has raised a credible challenge to the validity of the patent held by the plaintiffs. In such circumstances, the public interest in greater public access to a life saving drug will have to outweigh the public interest in granting an injunction to the patent holder.
Summary of conclusions
85. To summarise our conclusions:
(i) The failure by the plaintiffs to bring the facts concerning the filing of the subsequent applications for grant of a patent in respect of the Polypmorph B form of the compound to the notice of the Controller of Patents at the time of consideration of their application for patent for the compound of a combination of Polymorphs A and B was not consistent with the requirement of a full disclosure.
(ii) The change in the stand of the plaintiffs that the earlier patent U.S.‟498 (in respect of a mixture of Polymorphs A and B) did not FAO (O.S.) No. 188/2008 Page 54 of 57 disclose Polymorph B free of Polymorph A by stating that it covered all known and unknown forms of the compound, would admittedly have a direct impact on the question of patentability of either a compound of Polymorphs A and B or of Polymorph B free of Polymorph A. This made the full disclosure by the plaintiffs of all the facts pertaining not only to the „umbrella‟ compound but the crystal or other forms of the product to the Controller of Patents imperative. Such disclosure would have impacted the decision on the patentability of compound of Polymorphs A and B. When the defendant therefore questioned the validity of Patent No.196774 on the above ground, it did raise a more than credible challenge.
(iii) In an application seeking ad interim injunction in a suit for infringement of patent, it would be incumbent on the plaintiffs to make a full disclosure of the complete specification of the product whose patent is claimed to have been infringed. The plaintiffs will also have to disclose to Court the x-ray diffraction data of the product, particularly if it is a pharmaceutical drug. The plaintiffs have to make an unequivocal disclosure that the patent they hold covers the drug in question; whether there are any other pending applications seeking the grant of patent in respect of any derivatives or forms of the product for which they already hold a patent and the effect of such applications on the suit patent. (iv) The failure by the plaintiffs to disclose the complete specification of the product and the facts concerning the pending applications for Polymorph B led to the learned Single Judge not having the occasion to consider if in fact the suit patent covered Tarceva. Had these facts fully FAO (O.S.) No. 188/2008 Page 55 of 57 disclosed in the plaint and the entire specification of the patent held by the plaintiff together with X-ray diffraction data of Tarceva and Erlocip filed along with the plaint, it is possible that the plaintiff may have had difficulty in showing that the patent held by it (No.196774) covered Tarceva as well.
(v) To the extent that the defendant has raised a serious doubt whether the plaintiffs in fact hold a patent for the product sold in the tablet form as Tarceva, the plaintiffs must be held not to have been able to cross the first hurdle of showing that they have a prima facie case in their favour for grant of an order restraining the defendant from marketing Erlocip. The plaintiffs therefore ought to have been refused injunction for their failure to make out a prima facie case.
(vi) Notwithstanding the above, assuming that the plaintiffs held a patent for the product which was the subject matter of the suit for infringement, the grant of such patent to the plaintiffs will not ipso facto entitle them to an interim injunction if the defendant is able to satisfy the court that there is a serious question to be tried as to the validity of the patent. In the present case, the defendant has raised a credible challenge to the validity of the patent by raising a serious triable and substantial question that renders it vulnerable to challenge.
(vii) The question of general public access in our country to life saving drugs assumes great significance and the adverse impact on such access which the grant of injunction in a case like the instant one is likely to have, would have to be accounted for. This Court finds no ground to differ with the reasoning or the conclusions arrived at by the learned Single Judge on this aspect.
FAO (O.S.) No. 188/2008 Page 56 of 57 (viii) The defendant has been able to demonstrate prima facie that the plaintiffs do not hold a patent yet for the drug Tarceva, which is the Polymorph B form of the substance for which they hold a patent. Secondly, the defendant has raised a credible challenge to the validity of the patent held by the plaintiffs. In such circumstances, the public interest in greater public access to a life saving drug will have to outweigh the public interest in granting an injunction to the plaintiffs.
86. For all the aforementioned reasons this Court does not find merit in any of the submissions made on behalf of the appellant. It is however made clear that this order will not influence the decision of the learned Single judge in the pending application IA No.1402 of 2008 and the counter-claim of the defendant in the aforementioned suit.
87. The appeal is dismissed with costs quantified at Rs.5 lakhs which will be paid by the appellants/plaintiffs to the defendant within a period of four weeks. The interim order stands vacated. The applications are disposed of accordingly. S. MURALIDHAR, J.
CHIEF JUSTICE
APRIL 24, 2009
Rohtash/dk
FAO (O.S.) No. 188/2008 Page 57 of 57
Dr V. Nageswara Rao
(Expert) 14 October 2011
Intellectual Property Appellate Board has given an important verdict few days back on inventive step etc.
www.managingip.com/TopicList/324/.../Counterfeiting-in-China.htm...
R.Ramachandran
(Expert) 14 October 2011
Mr. Rohit Kumar Shukla,
Seems to be quite busy. He is yet to come back as to what he wants.
ROHIT KUMAR SHUKLA, LL.M.
(Querist) 18 October 2011
sir, if you have any more very recent cases on validity of patents under patent Act,1970 please provide me, i m very thankful to you.
